Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)
ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel. Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.
At 4 hours following LD administration
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort
Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \<75 years). ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.
At 30 days during MD therapy

Secondary Outcomes (17)

Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
At 30 minutes, 2 hours, and 4 hours following LD administration
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
At 30 Days and 90 days during MD therapy
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
30 minutes, 2 hours, and 4 hours following LD administration
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
30 days and at 90 days during MD therapy
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Randomization through end of study (90 days)
+12 more secondary outcomes

Study Arms (6)

Prasugrel 60/10 Primary

EXPERIMENTAL

Loading dose 60 mg followed by maintenance dose 10 mg/day

Drug: Prasugrel

Prasugrel 30/7.5 Primary

EXPERIMENTAL

Loading dose 30 mg followed by maintenance dose 7.5 mg/day

Drug: Prasugrel

Prasugrel 30/5 Primary

EXPERIMENTAL

Loading dose 30 mg followed by maintenance dose 5 mg/day

Drug: Prasugrel

Clopidogrel 300/75 Primary

ACTIVE COMPARATOR

Loading dose 300 mg followed by maintenance dose 75 mg/day

Drug: Clopidogrel

Prasugrel 30/5 Low Weight/Elderly

EXPERIMENTAL

Loading dose 30 mg followed by maintenance dose 5 mg/day

Drug: Prasugrel

Clopidogrel 300/75 Low Weight/Elderly

ACTIVE COMPARATOR

Loading dose 300 mg followed by maintenance dose 75 mg/day

Drug: Clopidogrel

Interventions

PrasugrelDRUG

Oral, daily, 90 days

Also known as: LY640315, Effient, Efient, CS-747

Prasugrel 30/5 Low Weight/ElderlyPrasugrel 30/5 PrimaryPrasugrel 30/7.5 PrimaryPrasugrel 60/10 Primary

ClopidogrelDRUG

Oral, daily, 90 days

Also known as: Plavix

Clopidogrel 300/75 Low Weight/ElderlyClopidogrel 300/75 Primary

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
A person who is of East or Southeast Asian descent
A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control

You may not qualify if:

A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
A person who has a severe liver disease, such as cirrhosis
A person who has a condition such as alcoholism, mental illness, or drug dependence

Contact the study team to confirm eligibility.