Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first participant was enrolled on 11 October 2006 and the last participant completed the study on 27 February 2009. Study participants were randomized from 855 centers in 43 countries.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants will already be hospitalized due to their acute condition, and must be enrolled and randomized within 24 hours of the onset of their most recent cardiac ischemic symptoms. Randomization should take place as soon as possible after presentation.

Reporting Groups

	Description
TICAGRELOR	Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL	Clopidogrel 75 mg once daily dose (ODD)

Participant Flow:   Overall Study

	TICAGRELOR	CLOPIDOGREL
STARTED	9333	9291
COMPLETED	9026	9036
NOT COMPLETED	307	255
Protocol Violation	7	2
Withdrawal by Subject	296	249
Reason unknown	2	4
Lost to Follow-up	2	0

Reporting Groups

	Description
TICAGRELOR	Ticagrelor 90 mg twice daily dose (BD)
CLOPIDOGREL	Clopidogrel 75 mg once daily dose (ODD)

Baseline Measures

	TICAGRELOR	CLOPIDOGREL	Total
Number of Participants   [units: participants]	9333	9291	18624
Age   [units: years] Mean ± Standard Deviation	62.1  ± 11.21	62.3  ± 11.21	62.2  ± 22.42
Gender   [units: Participants]
Female	2655	2633	5288
Male	6678	6658	13336

1.  Primary:

Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke   [ Time Frame: Randomization up to 12 months ]

2.  Primary:

Participants With Any Major Bleeding Event   [ Time Frame: First dosing up to 12 months ]

3.  Secondary:

Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization   [ Time Frame: Randomization up to 12 months ]

4.  Secondary:

Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke   [ Time Frame: Randomization up to 12 months ]

5.  Secondary:

Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.   [ Time Frame: Randomization up to 12 months ]

6.  Secondary:

Participants With MI Event   [ Time Frame: Randomization up to 12 months ]

7.  Secondary:

Participants With Death From Vascular Causes   [ Time Frame: Randomization up to 12 months ]

8.  Secondary:

Participants With Stroke   [ Time Frame: Randomization up to 12 months ]

9.  Secondary:

Participants With Death From Any Cause   [ Time Frame: Randomization up to 12 months ]

10.  Secondary:

Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding   [ Time Frame: First dosing up to 12 months ]

11.  Secondary:

Participants With Major or Minor Bleeding   [ Time Frame: First dosing up to 12 months ]

12.  Secondary:

Participants With Non-procedural Major Bleeding   [ Time Frame: First dosing up to 12 months ]

13.  Secondary:

Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding   [ Time Frame: First dosing up to 12 months   ]

14.  Secondary:

Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding   [ Time Frame: First dosing up to 12 months ]

15.  Secondary:

Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization   [ Time Frame: 1-week period following randomization ]

16.  Secondary:

Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization   [ Time Frame: 1-week period following randomization ]