A Phase 3 interventional study of Clopidogrel and Prasugrel in Acute Coronary Syndrome, sponsored by Eli Lilly and Company. Completed at 688 sites in 53 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-07.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's enrollment of 9,326 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prasugrel and Low-dose Commercially-available Aspirin
Drug: Prasugrel · Drug: Commercially-available Aspirin
Clopidogrel and Low-Dose Commercially-available Aspirin
Drug: Clopidogrel · Drug: Commercially-available Aspirin
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
Also known as: LY640315, Effient, Efient, CS-747
Low-dose aspirin, oral, as prescribed by physician through end of study
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: Randomization through end of study (30-month visit)
Percentage of Participants With a Composite Endpoint of CV Death and MI
The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: Randomization through end of study (30-month visit)
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.
Time frame: Randomization through end of study (30-month visit)
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: Randomization through end of study (30-month visit)
Platelet Aggregation Measures
Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.
Time frame: Day 30 and 12 Months
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
Time frame: Day 30 and 6 Months
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
Time frame: Day 30 and Month 6
Genotyping Related to Drug Metabolism
Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.
Time frame: Baseline
Economic and Quality of Life Outcomes
Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.
Time frame: Baseline and follow-up (24 months)
Summary of All Deaths
All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.
Time frame: Randomization through end of study (30-month visit)
| Milestone | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Started | 3620 | 1043 | 3623 | 1040 |
| Received at least 1 dose of study drug | 3590 | 1033 | 3590 | 1027 |
| Completed | 3421 | 957 | 3417 | 958 |
| Not completed | 199 | 86 | 206 | 82 |
| Withdrew: Withdrawal by subject | 194 | 83 | 202 | 80 |
| Withdrew: Physician decision | 3 | 2 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 | 3 | 1 |
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants with an event | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | 10.06 | 24.64 | 10.96 | 24.13 |
The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants with an event | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Percentage of Participants With a Composite Endpoint of CV Death and MI | 9.61 | 22.53 | 10.21 | 22.69 |
The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants with an event | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | 12.13 | 26.27 | 12.83 | 25.67 |
The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants with an event | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke | 10.61 | 27.04 | 11.12 | 26.83 |
Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.
| P2Y12 Reaction Units (PRU) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Day 30 | 93.280 ± 3.804 | 151.872 ± 8.148 | 193.489 ± 3.780 | 200.285 ± 8.238 |
| Month 12 (n=386, 76, 400, 103) | 94.529 ± 5.706 | 135.096 ± 14.631 | 199.003 ± 5.663 | 181.360 ± 14.380 |
Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
| picograms per milliliter (pg/mL) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Day 30 | 313.494 ± 1.039 | 1082.396 ± 1.093 | 319.345 ± 1.039 | 951.359 ± 1.092 |
| 6 Months (n=725, 125, 701, 174) | 253.434 ± 1.049 | 770.132 ± 1.135 | 250.982 ± 1.049 | 722.750 ± 1.130 |
C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.
| milligrams per liter (mg/L) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Day 30 | 2.330 ± 1.053 | 2.441 ± 1.150 | 2.287 ± 1.053 | 2.226 ± 1.150 |
| 6 Months (n=755, 143, 745, 178) | 2.272 ± 1.060 | 1.593 ± 1.173 | 2.149 ± 1.059 | 1.543 ± 1.170 |
Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.
| percentage participants with geneotype | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| UM, *1/*17 | 24.0 | 25.0 | 25.1 | 21.8 |
| UM, *17/*17 | 5.1 | 3.6 | 5.4 | 4.3 |
| EM (non-UM), *1/*1 | 38.8 | 42.1 | 35.7 | 41.2 |
| IM, *1/*2 | 18.6 | 18.3 | 19.8 | 19.7 |
| IM, *1/*3 | 0.8 | 0.6 | 0.5 | 0.6 |
| IM, *1/*4 | 0.4 | 0.0 | 0.1 | 0.3 |
| IM, *1/*6 | 0.0 | 0.2 | 0.0 | 0.2 |
| IM, *1/*8 | 0.1 | 0.5 | 0.4 | 0.3 |
| PM, *2/*2 | 3.9 | 2.2 | 4.3 | 3.8 |
| PM, *2/*3 | 0.3 | 0.2 | 0.3 | 0.3 |
| PM, *2/*4 | 0.0 | 0.2 | 0.2 | 0.2 |
| PM, *2/*6 | 0.0 | 0.0 | 0.0 | 0.0 |
| PM, *2/*8 | 0.0 | 0.0 | 0.0 | 0.0 |
| PM, *3/*3 | 0.0 | 0.0 | 0.2 | 0.0 |
| UNK, *1/*10 | 0.0 | 0.0 | 0.1 | 0.0 |
| UNK, *1/*13 | 0.0 | 0.2 | 0.0 | 0.0 |
| UNK, *1/*9 | 0.1 | 0.2 | 0.0 | 0.0 |
| UNK, *1/*9, *9/*17 | 0.0 | 0.0 | 0.0 | 0.0 |
| UNK, *13/*17 | 0.0 | 0.0 | 0.0 | 0.0 |
| UNK, *2/*13 | 0.0 | 0.0 | 0.0 | 0.0 |
| UNK, *2/*17 | 6.3 | 6.1 | 6.8 | 6.2 |
| UNK, *2/*9 | 0.0 | 0.0 | 0.1 | 0.0 |
| UNK, *3/*17 | 0.1 | 0.0 | 0.0 | 0.3 |
| UNK, *4/*17 | 0.2 | 0.2 | 0.2 | 0.0 |
| UNK, *4/*9 | 0.0 | 0.0 | 0.0 | 0.0 |
| UNK, *6/*17 | 0.0 | 0.0 | 0.0 | 0.2 |
| UNK, *8/*17 | 0.2 | 0.0 | 0.1 | 0.0 |
| UNK, *9/*17 | 0.0 | 0.0 | 0.0 | 0.0 |
| UNK, Undefined genotype | 0.7 | 0.6 | 0.5 | 0.6 |
Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.
| units on a scale | Prasugrel | Clopidogrel |
|---|---|---|
| Baseline, physical limitations | 67.8 ± 26.1 | 67.0 ± 26.5 |
| Baseline, angina frequency | 73.6 ± 22.9 | 73.1 ± 23.5 |
| 24 Months, physical limitations (n=420, 412) | 75.1 ± 24.4 | 74.5 ± 25.7 |
| 24 Months, angina frequency (n=420, 412) | 89.7 ± 20.0 | 89.5 ± 19.1 |
All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.
| participants | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older |
|---|---|---|---|---|
| Congestive Heart Failure | 10 | 21 | 13 | 23 |
| Cardiogenic Shock | 8 | 4 | 10 | 9 |
| Cardiac Rupture | 0 | 1 | 0 | 0 |
| Myocardial Infarction | 16 | 24 | 24 | 21 |
| Dysrhythmia | 5 | 2 | 6 | 3 |
| Stent Thrombosis | 0 | 0 | 0 | 0 |
| Directly Related to Revascularization-CABG or PCI | 1 | 1 | 1 | 1 |
| Intracranial Hemorrhage | 2 | 1 | 4 | 1 |
| Non-Hemorrhagic Stroke | 4 | 4 | 4 | 3 |
| Sudden death due to cardiovascular event | 75 | 39 | 70 | 43 |
| Pulmonary Embolism | 0 | 1 | 2 | 1 |
| Stroke, unknown type | 0 | 1 | 0 | 0 |
| Other Cardiovascular Event | 6 | 1 | 0 | 1 |
| Cardiovascular event, unknown type | 40 | 41 | 45 | 45 |
| Accidental | 1 | 0 | 1 | 1 |
| Trauma | 2 | 3 | 0 | 1 |
| Hemorrhage, not intracranial | 1 | 1 | 0 | 4 |
| Infection | 14 | 21 | 16 | 17 |
| Malignancy | 14 | 7 | 14 | 11 |
| Suicide | 1 | 0 | 0 | 0 |
| Other Non-Cardiovascular event | 8 | 4 | 8 | 6 |
| Cause unknown (nonadjudicated event) | 0 | 1 | 0 | 0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prasugrel | — | 1,573/4,623 (34%) | 2,581/4,623 (55.8%) |
| Clopidogrel | — | 1,594/4,617 (34.5%) | 2,494/4,617 (54%) |
| Event | Prasugrel | Clopidogrel |
|---|---|---|
| Angina unstableCardiac disorders | 290/4623 | 310/4617 |
| Acute myocardial infarctionCardiac disorders | 194/4623 | 194/4617 |
| Myocardial infarctionCardiac disorders | 142/4623 | 143/4617 |
| Angina pectorisCardiac disorders | 115/4623 | 129/4617 |
| Cardiac failure congestiveCardiac disorders | 83/4623 | 104/4617 |
| Atrial fibrillationCardiac disorders | 82/4623 | 69/4617 |
| PneumoniaInfections and infestations | 74/4623 | 76/4617 |
| Cardiac failureCardiac disorders | 68/4623 | 67/4617 |
| Non-cardiac chest painGeneral disorders | 66/4623 | 65/4617 |
| Sudden deathGeneral disorders | 45/4623 | 46/4617 |
| Event | Prasugrel | Clopidogrel |
|---|---|---|
| Angina pectorisCardiac disorders | 213/4623 | 250/4617 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 184/4623 | 112/4617 |
| ContusionInjury, poisoning and procedural complications | 175/4623 | 107/4617 |
| HypertensionVascular disorders | 161/4623 | 153/4617 |
| DizzinessNervous system disorders | 121/4623 | 142/4617 |
| CoughRespiratory, thoracic and mediastinal disorders | 140/4623 | 134/4617 |
| Oedema peripheralGeneral disorders | 90/4623 | 123/4617 |
| EcchymosisSkin and subcutaneous tissue disorders | 123/4623 | 65/4617 |
| Non-cardiac chest painGeneral disorders | 108/4623 | 120/4617 |
| HeadacheNervous system disorders | 109/4623 | 116/4617 |
| Age Continuous(years) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Mean | 61.4 ± 8.55 | 80.3 ± 4.29 | 61.5 ± 8.38 | 80.3 ± 4.39 | 65.7 ± 11.02 |
| Sex: Female, Male(Participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Female | 1309 | 520 | 1290 | 531 | 3650 |
| Male | 2311 | 523 | 2333 | 509 | 5676 |
| Race/Ethnicity, Customized(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Caucasian | 2362 | 767 | 2374 | 773 | 6276 |
| African | 87 | 14 | 72 | 12 | 185 |
| Hispanic | 321 | 109 | 346 | 86 | 862 |
| Asian | 821 | 147 | 800 | 164 | 1932 |
| Other | 29 | 6 | 30 | 5 | 70 |
| Unknown | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Portugal | 18 | 11 | 14 | 11 | 54 |
| Philippines | 58 | 7 | 48 | 14 | 127 |
| Taiwan | 6 | 6 | 4 | 9 | 25 |
| Slovakia | 62 | 20 | 60 | 20 | 162 |
| Greece | 14 | 8 | 10 | 11 | 43 |
| Costa Rica | 5 | 1 | 2 | 2 | 10 |
| Thailand | 30 | 17 | 36 | 10 | 93 |
| Ukraine | 326 | 28 | 311 | 42 | 707 |
| Chile | 28 | 15 | 33 | 13 | 89 |
| Italy | 71 | 44 | 70 | 47 | 232 |
| India | 513 | 56 | 508 | 64 | 1141 |
| France | 29 | 22 | 29 | 19 | 99 |
| Denmark | 21 | 7 | 17 | 10 | 55 |
| Korea, Republic of | 35 | 7 | 33 | 7 | 82 |
| Panama | 29 | 7 | 24 | 10 | 70 |
| Turkey | 76 | 24 | 81 | 19 | 200 |
| Czech Republic | 37 | 31 | 32 | 38 | 138 |
| Mexico | 38 | 15 | 40 | 16 | 109 |
| Canada | 58 | 14 | 61 | 13 | 146 |
| Brazil | 154 | 27 | 147 | 34 | 362 |
| Romania | 103 | 26 | 105 | 23 | 257 |
| Croatia | 63 | 28 | 60 | 31 | 182 |
| Sweden | 4 | 3 | 6 | 1 | 14 |
| United States | 430 | 133 | 446 | 116 | 1125 |
| Serbia | 42 | 4 | 40 | 5 | 91 |
| Spain | 13 | 8 | 10 | 12 | 43 |
| Ireland | 5 | 4 | 6 | 3 | 18 |
| Israel | 75 | 33 | 85 | 21 | 214 |
| Russian Federation | 128 | 22 | 135 | 14 | 299 |
| Colombia | 40 | 21 | 45 | 17 | 123 |
| Switzerland | 6 | 4 | 4 | 6 | 20 |
| Malaysia | 35 | 7 | 33 | 9 | 84 |
| Peru | 58 | 19 | 67 | 12 | 156 |
| Australia | 13 | 6 | 15 | 7 | 41 |
| South Africa | 27 | 11 | 27 | 12 | 77 |
| Netherlands | 55 | 23 | 53 | 24 | 155 |
| Tunisia | 20 | 3 | 20 | 4 | 47 |
| China | 126 | 38 | 120 | 44 | 328 |
| Finland | 3 | 3 | 5 | 2 | 13 |
| Lithuania | 29 | 8 | 32 | 4 | 73 |
| Austria | 6 | 6 | 6 | 5 | 23 |
| Malta | 9 | 1 | 10 | 2 | 22 |
| United Kingdom | 33 | 21 | 40 | 12 | 106 |
| Egypt | 65 | 1 | 62 | 4 | 132 |
| Hungary | 86 | 43 | 87 | 44 | 260 |
| Argentina | 120 | 58 | 138 | 41 | 357 |
| Poland | 137 | 59 | 129 | 68 | 393 |
| Belgium | 7 | 7 | 7 | 8 | 29 |
| Singapore | 2 | 5 | 5 | 1 | 13 |
| Bulgaria | 216 | 48 | 209 | 55 | 528 |
| Germany | 46 | 20 | 46 | 21 | 133 |
| New Zealand | 10 | 3 | 10 | 3 | 26 |
| History of Diabetes(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Yes | 1393 | 363 | 1418 | 365 | 3539 |
| No | 2221 | 678 | 2193 | 675 | 5767 |
| Unknown | 6 | 2 | 12 | 0 | 20 |
| History of Myocardial Infarction (MI)(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Yes | 1556 | 426 | 1612 | 393 | 3987 |
| No | 2035 | 603 | 1988 | 633 | 5259 |
| Unknown | 29 | 14 | 23 | 14 | 80 |
| History of Coronary Revascularization (PCI or CABG)(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Yes | 1279 | 330 | 1365 | 299 | 3273 |
| No | 2332 | 703 | 2239 | 734 | 6008 |
| Unknown | 9 | 10 | 19 | 7 | 45 |
| Clinical Presentation of UA or NSTEMI(participants) | Prasugrel: <75 Years of Age | Prasugrel: 75 Years of Age or Older | Clopidogrel: <75 Years of Age | Clopidogrel: 75 Years of Age or Older | Total |
|---|---|---|---|---|---|
| Unstable Angina | 963 | 166 | 981 | 192 | 2302 |
| Non-ST-segment Elevation Myocardial Infarction | 2453 | 829 | 2434 | 804 | 6520 |
| Unknown/Did not meet criteria | 204 | 48 | 208 | 44 | 504 |
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The record gives a start of Jun 2008, a primary completion of Apr 2012 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
Results were first posted in May 2013, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Prasugrel