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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Shunichi Homma, Columbia University
ClinicalTrials.gov Identifier:
NCT00041938
First received: July 19, 2002
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: January 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Heart Disease
Stroke
Ischemic Heart Disease
Myocardial Infarction
Interventions: Drug: aspirin
Drug: Warfarin

  Participant Flow
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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 



  Baseline Characteristics
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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.
No text entered.

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 


  Outcome Measures
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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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. J.L.P. (Seamus) Thompson
Organization: Columbia University
phone: 212-342-1252
e-mail: jlt12@columbia.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Shunichi Homma, Columbia University
ClinicalTrials.gov Identifier: NCT00041938     History of Changes
Other Study ID Numbers: AAAC1093
U01NS039143-01 ( US NIH Grant/Contract Award Number )
R01NS39154
CRC
Study First Received: July 19, 2002
Results First Received: January 3, 2013
Last Updated: August 29, 2014
Health Authority: United States: Federal Government