Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited 2305 patients at 176 sites in 11 countries, between 10/1/2002 and 1/31/2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Intent-to-treat trial - all randomized patients followed and analyzed.

Reporting Groups

	Description
Aspirin	Aspirin : 325 mg per day
Warfarin	Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75

Participant Flow:   Overall Study

	Aspirin	Warfarin
STARTED	1163	1142
Completed Follow-up	761	745
Primary Endpoint	320	302
Only Vital Status Known	44	46
Lost to Follow-up	18	17
Withdrew Consent	20	14
COMPLETED	1125	1111
NOT COMPLETED	38	31

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Aspirin	Aspirin : 325 mg per day
Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75
Total	Total of all reporting groups

Baseline Measures

	Aspirin	Warfarin	Total
Overall Participants Analyzed  [Units: Participants]	1163	1142	2305
Age  [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	732	706	1438
>=65 years	431	436	867
Age  [Units: Years] Mean (Standard Deviation)	61  (11.1)	61  (11.6)	61  (11.3)
Gender, Customized  [Units: Participants]
Male	936	904	1840
Female	224	236	460
Unknown	3	2	5
Region of Enrollment  [Units: Participants]
North America	546	573	1119
Europe	567	527	1094
Argentina	50	42	92

1.  Primary:

Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death   [ Time Frame: From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years ]

2.  Secondary:

Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.   [ Time Frame: From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. ]

3.  Other Pre-specified:

Event Rate Per 100 Patient-years for Ischemic Stroke   [ Time Frame: From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years ]

4.  Other Pre-specified:

Event Rate Per 100 Patient-years for Intracerebral Hemorrhage   [ Time Frame: From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years ]

5.  Other Pre-specified:

Event Rate Per 100 Patient-years for Death   [ Time Frame: From date of randomization to date of death component of primary composite outcome, up to 6 years ]

6.  Other Pre-specified:

Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome   [ Time Frame: From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years ]

7.  Other Pre-specified:

Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.   [ Time Frame: From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years ]

8.  Other Pre-specified:

Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome   [ Time Frame: From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years ]

9.  Other Pre-specified:

Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome   [ Time Frame: From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years ]

10.  Other Pre-specified:

Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome   [ Time Frame: From date of randomization to date of death component of secondary composite outcome, up to 6 years ]

11.  Other Pre-specified:

Rate Per 100 Patient Years of Major Hemorrhage   [ Time Frame: From date of randomization until end of scheduled follow-up, up to 6 years ]

12.  Other Pre-specified:

Rate Per 100 Patient-years of Minor Hemorrhage.   [ Time Frame: From date of randomization until the end of scheduled follow-up, up to 6 years ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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