A Phase 3 interventional study of Placebo and Prasugrel in Acute Coronary Syndromes, sponsored by Eli Lilly and Company. Completed at 153 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-28.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).
This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.
The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's enrollment of 4,033 is above the median of 200 across 880 interventional studies indexed under Acute Coronary Syndrome.
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A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Drug: Placebo · Drug: Prasugrel
A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days
Drug: Prasugrel
Administered once orally
Administered orally
Also known as: LY640315, Efient, Effient, CS-747
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First loading dose (LD) through 7 days after first LD
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First loading dose (LD) through 7 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First LD through 30 days after first LD
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
Time frame: Baseline, before PCI (not greater than 48 hours after randomization)
Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time frame: First loading dose (LD) through 7 days after first LD
Summary of All-Cause Death
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
Time frame: Randomization through 30 days
| Milestone | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Started | 1996 | 2037 |
| Received at least 1 dose of study drug | 1996 | 2037 |
| Completed | 1924 | 1958 |
| Not completed | 72 | 79 |
| Withdrew: Death | 21 | 16 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Sponsor decision | 3 | 7 |
| Withdrew: Physician decision | 19 | 21 |
| Withdrew: Withdrawal by subject | 14 | 19 |
| Withdrew: Entry criteria not met | 11 | 14 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout | 9.77 | 9.97 |
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | 7.57 | 8.64 |
The percentage of participants is the total number of participants experiencing a CV death, MI, or 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 | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) | 7.21 | 7.07 |
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) | 6.51 | 6.63 |
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) | 7.31 | 7.71 |
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD) | 1.10 | 0.69 |
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD) | 0.25 | 0.10 |
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD) | 8.52 | 9.47 |
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
| ratio of assayed troponin/ULN | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) | -11.24 ± 8.93 | 2.82 ± 8.42 |
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
| percentage of participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding | 1.35 | 2.55 |
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
| participants | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Congestive Heart Failure | 1 | 0 |
| Cardiogenic Shock | 5 | 5 |
| During or Immediately Following a CABG Procedure | 5 | 1 |
| During or Immediately Following a PCI Procedure | 2 | 1 |
| Myocardial Infarction | 2 | 1 |
| Dysrhythmia | 0 | 1 |
| Sudden Cardiac Death | 4 | 1 |
| Intracranial Hemorrhage | 1 | 1 |
| Stroke, non-hemorrhagic | 0 | 1 |
| Other Cardiovascular | 2 | 2 |
| Non-Cardiac Hemorrhage, Not Intracranial | 0 | 1 |
| Infection | 1 | 0 |
| Cancer | 0 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non Pre-treatment | — | 167/1,996 (8.4%) | 860/1,996 (43.1%) |
| Pre-treatment | — | 206/2,037 (10.1%) | 876/2,037 (43%) |
| Event | Non Pre-treatment | Pre-treatment |
|---|---|---|
| Percutaneous coronary interventionSurgical and medical procedures | 10/1996 | 16/2037 |
| Myocardial infarctionCardiac disorders | 10/1996 | 15/2037 |
| Chest painGeneral disorders | 8/1996 | 9/2037 |
| Cardiogenic shockCardiac disorders | 5/1996 | 7/2037 |
| Ventricular fibrillationCardiac disorders | 5/1996 | 7/2037 |
| Acute myocardial infarctionCardiac disorders | 3/1996 | 6/2037 |
| Angina unstableCardiac disorders | 2/1996 | 6/2037 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/1996 | 6/2037 |
| Procedural haemorrhageInjury, poisoning and procedural complications | 4/1996 | 6/2037 |
| Vascular pseudoaneurysmInjury, poisoning and procedural complications | 2/1996 | 6/2037 |
| Event | Non Pre-treatment | Pre-treatment |
|---|---|---|
| HaematomaVascular disorders | 57/1996 | 96/2037 |
| HypertensionVascular disorders | 88/1996 | 90/2037 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 87/1996 | 72/2037 |
| Chest painGeneral disorders | 55/1996 | 47/2037 |
| Myocardial infarctionCardiac disorders | 49/1996 | 41/2037 |
| HeadacheNervous system disorders | 48/1996 | 44/2037 |
| HyperlipidaemiaMetabolism and nutrition disorders | 42/1996 | 26/2037 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 28/1996 | 38/2037 |
| Atrial fibrillationCardiac disorders | 28/1996 | 36/2037 |
| PyrexiaGeneral disorders | 24/1996 | 33/2037 |
All randomized participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Non Pre-treatment | Pre-treatment | Total |
|---|---|---|---|
| Mean | 63.59 ± 11.239 | 63.80 ± 11.270 | 63.69 ± 11.254 |
| Sex: Female, Male(Participants) | Non Pre-treatment | Pre-treatment | Total |
|---|---|---|---|
| Female | 558 | 552 | 1110 |
| Male | 1438 | 1485 | 2923 |
Showing the first 100 of 153 sites across 19 countries.
The record gives a start of Dec 2009, a primary completion of Jan 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 1 year 1 month after primary completion.
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Studies of the drug tested here: Prasugrel