Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Acute Coronary Syndromes (ACS) includes subjects presenting with unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Prasugrel	Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
Clopidogrel	Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

Participant Flow:   Overall Study

	Prasugrel	Clopidogrel
STARTED	6813 [1]	6795 [2]
COMPLETED	6403	6401
NOT COMPLETED	410	394
Withdrawal of consent	342	323
Less than 6 months on study drug	9	7
Unable to attend termination visit	53	51
Lost to follow up	6	10
Other	0	3

Reporting Groups

	Description
Prasugrel	Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
Clopidogrel	Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

Baseline Measures

	Prasugrel	Clopidogrel	Total
Number of Participants   [units: participants]	6813	6795	13608
Age   [units: years] Mean ± Standard Deviation	60.9  ± 11.2	60.9  ± 11.4	60.9  ± 11.3
Gender   [units: participants]
Female	1705	1818	3523
Male	5108	4977	10085
Race/Ethnicity, Customized   [units: Participants]
Caucasian	6263	6274	12537
African	205	187	392
Hispanic	269	256	525
Asian	60	64	124
Other	16	14	30
Region of Enrollment   [units: participants]
North America	2164	2146	4310
South America	270	264	534
Europe	3436	3439	6875
Middle East	606	613	1219
Africa	204	200	404
Pacifica	133	133	266

1.  Primary:

Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization up to 15 months ]

2.  Secondary:

Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events   [ Time Frame: First dose of study drug up to 15 months (while at risk) ]

3.  Secondary:

Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)   [ Time Frame: Randomization to 30 days; randomization to 90 days ]

4.  Secondary:

Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization to 30 days; randomization to 90 days ]

5.  Secondary:

Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events   [ Time Frame: Randomization up to 15 months ]

6.  Secondary:

Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke   [ Time Frame: Randomization up to 15 months ]