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

• Net clinical benefit of all-cause death, Myocardial Infarction (MI), stroke, or all Coronary Artery Bypass Graft (CABG) and non-CABG Thrombolysis in Myocardial Infarction (TIMI) major bleeding [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]
• Incidence of Cardiovascular (CV) death, MI, or stroke through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Incidence of CV death or MI through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Incidence of CV death, MI, or Urgent Revascularization (UR) through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Incidence of CV death through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Incidence of definite or probable stent thrombosis according to the Academic Research Consortium criteria through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Net clinical benefit of all-cause death, MI, stroke or all TIMI major bleeding through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
• Change in Troponin from baseline to PCI [ Time Frame: Baseline to not greater than 48 hours after randomization ] [ Designated as safety issue: Yes ]
• Incidence of all CABG or non-CABG TIMI major bleeding [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) subjects with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

This trial consists of two arms. The first arm is a pre-treatment arm where subjects 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 subjects are proceeding to PCI. Subsequently, subjects will receive daily maintenance doses of prasugrel until day 30. Subjects 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.

The second arm is a non pre-treatment arm. Subjects 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, subjects will receive daily maintenance doses of prasugrel until day 30. Subjects 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.

• Drug: Placebo
  Administered once orally
• Drug: Prasugrel
  Administered orally
  Other Names:

  • LY640315
  • Efient
  • Effient
  • CS-747

• Experimental: Non pre-treatment
  A placebo oral loading dose is given at the time of diagnosis and a 60mg oral loading dose of Prasugrel is given at the time of PCI followed by 5mg or 10mg oral daily maintenance dose of prasugrel for 30 days.
  Interventions:

  • Drug: Placebo
  • Drug: Prasugrel
• Experimental: Split Loading Dose
  A 30mg oral loading dose of prasugrel is given at diagnosis and a 30mg oral dose of prasugrel is given at the time of PCI followed by 5mg or 10mg oral daily maintenance dose of prasugrel for 30 days
  Intervention: Drug: Prasugrel

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, ASA, and a 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