Phase 3 N=4,033 Randomized Quadruple-blind Treatment

A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

Acute Coronary Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT01015287 ↗

Enrolled (actual)

4,033

Serious AEs

9.3%

Results posted

Feb 2014

Primary outcome: Primary: 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 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Prasugrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	—
SECONDARY 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	—
SECONDARY 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	—
SECONDARY 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	—
SECONDARY 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	—
SECONDARY Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)	1.10; 0.69	—
SECONDARY 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	—
SECONDARY 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	—
SECONDARY Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)	-11.24; 2.82	—
SECONDARY 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	—

Summary

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).

Eligibility Criteria

Inclusion Criteria

Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Exclusion Criteria

Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
Have cardiogenic shock
Have refractory ventricular arrhythmias
Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
Have had cardiac arrest within 1 week of entry or randomization into the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01015287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.