CompletedNCT01115738Updated Nov 20, 2012Results posted

Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients

A Phase 2 interventional study of Prasugrel and Clopidogrel in Acute Coronary Syndrome, sponsored by Eli Lilly and Company. Completed at 3 sites in India. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-11-20.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 282
Allocation: Randomized
Ages: 18 Years to 74 Years
Sex: All

Study summary

This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel.

Conditions studied

Acute Coronary Syndrome

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Keywords

Plavix, Effient

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 282 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participants hospitalized with acute coronary syndrome (ACS) [unstable angina (UA), non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI)] as determined by the investigator, and who are anticipated to undergo percutaneous coronary intervention (PCI) as a treatment for the ACS event within 24 hours of the clopidogrel/placebo loading dose
Participants provide signed informed consent form (ICF)
Participants weigh at least 60 kilograms (kg) at the time of screening
Women of child-bearing potential (that is, women who are not surgically or chemically sterilized and who are between menarche and 1-year postmenopause), test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test

Exclusion criteria

Exclusion Criteria:

Have cardiogenic shock at the time of randomization (systolic blood pressure greater than 90 millimeters of mercury (mm Hg) associated with clinical evidence of end-organ hypoperfusion, or participants requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion
Have refractory ventricular arrhythmias
Have New York Heart Association (NYHA) Class IV congestive heart failure
Have systolic blood pressure greater than 180 mm Hg, or diastolic blood pressure greater than 100 mm Hg on more than 1 assessment at any time from participant presentation of ACS treatment to enrollment
Have received fibrin-specific fibrinolytic therapy less than 24 hours prior to randomization
Have received nonfibrin-specific fibrinolytic therapy less than 48 hours prior to randomization
Have active internal bleeding or history of bleeding diathesis
Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
Prior history of ischemic or hemorrhagic stroke
Intracranial neoplasm, arteriovenous malformation, or aneurysm
Prior history of transient ischemic attack (TIA)
Have an International Normalized Ratio (INR) known to be greater than 1.5 at the time of evaluation
Have a platelet count of less than 100,000 per cubic millimeter (mm\^3) at the time of evaluation
Have anemia [hemoglobin (Hgb) less than 10 grams per deciliter (g/dL)] at the time of evaluation
Have received 1 or more doses of a thienopyridine (ticlopidine, clopidogrel, or prasugrel) or other adenosine diphosphate (ADP) receptor inhibitor within 10 days prior to screening
Have been administered glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitor within the past 7 days or planned use of a GPIIb/IIIa inhibitor during PCI
Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), which cannot be safely discontinued for the duration of the study.
Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued during the study
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have previously completed or withdrawn from this study or any other study investigating prasugrel
Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding
Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator, is associated with reduced survival over the expected treatment period
Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension)
Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine, clopidogrel or prasugrel)
May be unable to cooperate with protocol requirements and follow-up procedures

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 282 participants (actual)

Study arms

Placebo comparator
Placebo and 60 milligram (mg) Prasugrel
Placebo loading dose administered once orally before percutaneous coronary intervention (PCI) and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
Drug: Prasugrel · Drug: Placebo
Experimental
600 mg Clopidogrel and 60 mg Prasugrel
600-mg clopidogrel loading dose administered once orally before PCI and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
Drug: Prasugrel · Drug: Clopidogrel
Experimental
600 mg Clopidogrel and 30 mg Prasugrel
600-mg clopidogrel loading dose administered once orally before PCI and 30-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
Drug: Prasugrel · Drug: Clopidogrel

Interventions

DrugPrasugrel
Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
Also known as: LY640315
DrugClopidogrel
Loading dose administered once orally.
DrugPlacebo
Loading dose administered once orally

What researchers measure

Primary outcomes

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)
ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Time frame: 6 hours after prasugrel loading dose

Secondary outcomes

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Time frame: Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit
Time frame: Baseline, 72 hours
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin
Time frame: Baseline, 72 hours
Percentage of Inhibition of Platelet Aggregation
Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-\[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Time frame: Baseline and 2 and 6 and 24 and 72 hours after loading dose
Percentage of Poor Responders
Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.
Time frame: Baseline and 2 and 6 and 24 and 72 hours after loading dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.
Time frame: Baseline through 72 hours after prasugrel loading dose
P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (\*1/\*1, \*1/\*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (\*2/\*2, \*1/\*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.
Time frame: Baseline
P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (\*1/\*1, \*1/\*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (\*2/\*2, \*1/\*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.
Time frame: 6 hours after prasugrel loading dose

Results

Posted Oct 26, 2012

Participant flow

Participant flow — Overall Study
Milestone	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Started	110	83	89
Received any treatment	109	79	88
Pharmacodynamic (pd) population	52	47	50
Completed	85	62	62
Not completed	25	21	27
Withdrew: Death	1	0	0
Withdrew: Lost to follow-up	0	0	1
Withdrew: Physician decision	18	15	17
Withdrew: Withdrawal by subject	6	6	9

Outcome measures

PrimaryAdenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)

ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.

Time frame:: 6 hours after prasugrel loading dose
Reported as:: Least squares mean · PRU

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)
PRU	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)	57.86 ± 11.86	35.61 ± 12.36	53.92 ± 11.74

Statistical analysis

Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.188 (P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 22.24 · 95% CI -10.98 to 55.47Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.809 (P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 3.93 · 95% CI -28.20 to 36.07Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.

SecondaryAdenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)

Time frame:: Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose
Reported as:: Least squares mean · PRU

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
PRU	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Baseline	265.51 ± 13.01	248.58 ± 13.99	229.62 ± 13.38
2 Hours after Prasugrel LD	122.55 ± 17.28	113.10 ± 18.07	117.10 ± 17.47
24 Hours after Prasugrel LD	62.73 ± 10.43	34.05 ± 10.88	51.43 ± 10.72
72 Hours after Prasugrel LD	56.95 ± 8.40	48.08 ± 9.09	60.29 ± 9.05

Statistical analysis

Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.370 (P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 16.93 · 95% CI -20.26 to 54.12Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.052 (P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 35.89 · 95% CI -0.29 to 72.06Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.703 (P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 9.45 · 95% CI -39.55 to 58.45Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.823 (P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 5.45 · 95% CI -42.53 to 53.44Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.054 (P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 28.69 · 95% CI -0.47 to 57.84Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.436 (P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 11.30 · 95% CI -17.29 to 39.90Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.463 (P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 8.87 · 95% CI -14.96 to 32.71Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.777 (P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -3.34 · 95% CI -26.62 to 19.94Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.

SecondaryMean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit

Time frame:: Baseline, 72 hours
Reported as:: Mean · proportion of 1.0

Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit
proportion of 1.0	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit	0.0 ± 0.04	0.0 ± 0.03	0.0 ± 0.03

SecondaryMean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin

Time frame:: Baseline, 72 hours
Reported as:: Mean · gram per deciliter (g/dL)

Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin
gram per deciliter (g/dL)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin	-0.9 ± 1.41	-0.6 ± 1.03	-0.6 ± 1.04

SecondaryPercentage of Inhibition of Platelet Aggregation

Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-\[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.

Time frame:: Baseline and 2 and 6 and 24 and 72 hours after loading dose
Reported as:: Least squares mean · percentage of inhibition

Percentage of Inhibition of Platelet Aggregation
percentage of inhibition	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Baseline	9.71 ± 3.44	13.02 ± 3.70	14.94 ± 3.54
2 Hours after Prasugrel LD	56.04 ± 5.88	58.75 ± 6.16	54.89 ± 5.95
6 Hours after Prasugrel LD	79.87 ± 3.95	86.77 ± 4.13	78.55 ± 3.93
24 Hours after Prasugrel LD	77.57 ± 3.56	87.64 ± 3.74	78.56 ± 3.68
72 Hours after Prasugrel LD	78.48 ± 2.95	83.51 ± 3.28	78.17 ± 3.27

Statistical analysis

Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.505 (P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -3.31 · 95% CI -13.10 to 6.48Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.278 (P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -5.23 · 95% CI -14.74 to 4.27Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.749 (P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -2.71 · 95% CI -19.44 to 14.02Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.890 (P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 1.15 · 95% CI -15.24 to 17.53Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.223 (P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -6.89 · 95% CI -18.02 to 4.24Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.808 (P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 1.33 · 95% CI -9.44 to 12.10Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.049 (P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -10.07 · 95% CI -20.11 to -0.04Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.842 (P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Median difference (final values): -0.99 · 95% CI -10.85 to 8.86Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 60-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.247 (P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): -5.03 · 95% CI -13.58 to 3.52Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.
Placebo and 60-mg Prasugrel vs 600-mg Clopidogrel and 30-mg Prasugrel · Mixed Model Repeated Measures Analysis · p = 0.942 (P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.) · Mean difference (final values): 0.31 · 95% CI -8.09 to 8.71Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.

SecondaryPercentage of Poor Responders

Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.

Time frame:: Baseline and 2 and 6 and 24 and 72 hours after loading dose
Reported as:: Number · percentage of participants

Percentage of Poor Responders
percentage of participants	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Baseline	68.1	66.7	51.2
2 Hours after Prasugrel LD	23.3	12.8	21.4
6 Hours after Prasugrel LD	11.6	5.3	4.4
24 Hours after Prasugrel LD	9.5	2.9	8.8
72 Hours after Prasugrel LD	0	0	0

SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.

Time frame:: Baseline through 72 hours after prasugrel loading dose
Reported as:: Number · participants

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
participants	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Serious Adverse Events	2	8	1
Nonserious Adverse Events	37	31	31

SecondaryP2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (\*1/\*1, \*1/\*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (\*2/\*2, \*1/\*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.

Time frame:: Baseline
Reported as:: Least squares mean · PRU

P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
PRU	Clopidogrel at Baseline -CYP2C19 EM	Clopidogrel at Baseline - CYP2C19 RM
P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)	243.549 ± 11.244	240.100 ± 17.955

Statistical analysis

Clopidogrel at Baseline -CYP2C19 EM vs Clopidogrel at Baseline - CYP2C19 RM · ANOVA · p = 0.8711 · Mean difference (final values): 3.449 · 95% CI -38.81 to 45.71

SecondaryP2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)

Time frame:: 6 hours after prasugrel loading dose
Reported as:: Least squares mean · PRU

P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
PRU	Placebo and 60 mg Prasugrel-CYP2C19 EM	Placebo and 60 mg Prasugrel -CYP2C19 RM	600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM	600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM	600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM	600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)	39.036 ± 11.397	47.750 ± 30.153	20.190 ± 13.160	23.625 ± 21.321	36.478 ± 12.575	24.778 ± 20.102

Statistical analysis

Placebo and 60 mg Prasugrel-CYP2C19 EM vs Placebo and 60 mg Prasugrel -CYP2C19 RM · ANOVA · p = 0.7875 · Mean difference (final values): -8.714 · 95% CI -72.78 to 55.36
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM vs 600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM · ANOVA · p = 0.8913 · Mean difference (final values): -3.435 · 95% CI -53.23 to 46.37
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM vs 600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM · ANOVA · p = 0.6229 · Mean difference (final values): 11.700 · 95% CI -35.43 to 58.83

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo and 60-mg Prasugrel	—	2/109 (1.8%)	37/109 (33.9%)
600-mg Clopidogrel and 60-mg Prasugrel	—	8/79 (10.1%)	31/79 (39.2%)
600-mg Clopidogrel and 30-mg Prasugrel	—	1/88 (1.1%)	31/88 (35.2%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
Coronary artery occlusionCardiac disorders	0/109	2/79	0/88
Acute myocardial infarctionCardiac disorders	0/109	1/79	0/88
Cardiac tamponadeCardiac disorders	0/109	1/79	0/88
Coronary artery diseaseCardiac disorders	0/109	1/79	0/88
Pericardial effusionCardiac disorders	0/109	1/79	0/88
Ventricular fibrillationCardiac disorders	0/109	1/79	0/88
HaematemesisGastrointestinal disorders	0/109	1/79	0/88
Femoral artery dissectionVascular disorders	0/109	1/79	0/88
HypotensionVascular disorders	0/109	1/79	0/88
Myocardial infarctionCardiac disorders	0/109	0/79	1/88

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel
High density lipoprotein decreasedInvestigations	8/109	7/79	7/88
HypokalaemiaMetabolism and nutrition disorders	6/109	3/79	6/88
DyslipidaemiaMetabolism and nutrition disorders	5/109	4/79	2/88
HeadacheNervous system disorders	3/109	4/79	4/88
InsomniaPsychiatric disorders	0/109	3/79	0/88
HypercholesterolaemiaMetabolism and nutrition disorders	4/109	1/79	0/88
HypomagnesaemiaMetabolism and nutrition disorders	3/109	1/79	3/88
ConstipationGastrointestinal disorders	3/109	0/79	1/88
NauseaGastrointestinal disorders	3/109	2/79	2/88
Angina pectorisCardiac disorders	0/109	2/79	0/88

Baseline characteristics

Age Continuous
Age Continuous(years)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
Mean	58.1 ± 9.47	57.5 ± 9.12	58.7 ± 8.07	58.1 ± 8.86

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
Female	13	8	9	30
Male	39	39	41	119

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
Hispanic or Latino	13	14	13	40
Not Hispanic or Latino	30	28	30	88
Unknown or Not Reported	9	5	7	21

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
American Indian or Alaska Native	0	0	0	0
Asian	13	12	9	34
Native Hawaiian or Other Pacific Islander	1	2	0	3
Black or African American	1	2	3	6
White	37	31	38	106
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
India	10	11	9	30
Argentina	2	4	4	10
Brazil	6	5	6	17
Australia	1	3	2	6
Canada	11	8	10	29
Mexico	8	6	5	19
Turkey	7	2	7	16
United States	7	8	7	22

Qualifying Acute Coronary Syndrome (ACS) Event
Qualifying Acute Coronary Syndrome (ACS) Event(participants)	Placebo and 60-mg Prasugrel	600-mg Clopidogrel and 60-mg Prasugrel	600-mg Clopidogrel and 30-mg Prasugrel	Total
Unstable Angina	21	16	22	59
Non-ST-elevation Myocardial Infarction	20	18	21	59
ST-elevation Myocardial Infarction	11	13	7	31

Study locations

3 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bangalore, 560099, India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyderabaad, 500 001, India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Delhi, 110 060, India

References and documents

Publications

Diodati JG, Saucedo JF, Cardillo TE, Jakubowski JA, Henneges C, Effron MB, Lipkin FR, Walker JR, Duvvuru S, Sundseth SS, Fisher HN, Angiolillo DJ. Transferring from clopidogrel loading dose to prasugrel loading dose in acute coronary syndrome patients. High on-treatment platelet reactivity analysis of the TRIPLET trial. Thromb Haemost. 2014 Aug;112(2):311-22. doi: 10.1160/TH13-09-0747. Epub 2014 Apr 10. PubMed 24718367 ↗
Diodati JG, Saucedo JF, French JK, Fung AY, Cardillo TE, Henneges C, Effron MB, Fisher HN, Angiolillo DJ. Effect on platelet reactivity from a prasugrel loading dose after a clopidogrel loading dose compared with a prasugrel loading dose alone: Transferring From Clopidogrel Loading Dose to Prasugrel Loading Dose in Acute Coronary Syndrome Patients (TRIPLET): a randomized controlled trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):567-74. doi: 10.1161/CIRCINTERVENTIONS.112.000063. Epub 2013 Sep 24. PubMed 24065443 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01115738
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: May 4, 2010
Start date: May 2010
Primary completion: Nov 2011
Completion: Nov 2011
Results posted: Oct 26, 2012
Last update: Nov 20, 2012

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients

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