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

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ClinicalTrials.gov Identifier: NCT00041938
Recruitment Status : Completed
First Posted : July 22, 2002
Results First Posted : May 14, 2013
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Shunichi Homma, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Heart Disease
Stroke
Ischemic Heart Disease
Myocardial Infarction
Interventions Drug: aspirin
Drug: Warfarin
Enrollment 2305
Recruitment Details Recruited 2305 patients at 176 sites in 11 countries, between 10/1/2002 and 1/31/2010.
Pre-assignment Details Intent-to-treat trial - all randomized patients followed and analyzed.
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description Aspirin : 325 mg per day Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Period Title: Overall Study
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
Arm/Group Title Aspirin Warfarin Total
Hide Arm/Group Description Aspirin : 325 mg per day Warfarin : INR 2.5-3.0; target INR 2.75 Total of all reporting groups
Overall Number of Baseline Participants 1163 1142 2305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1163 participants 1142 participants 2305 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
732
  62.9%
706
  61.8%
1438
  62.4%
>=65 years
431
  37.1%
436
  38.2%
867
  37.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1163 participants 1142 participants 2305 participants
61  (11.1) 61  (11.6) 61  (11.3)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1163 participants 1142 participants 2305 participants
Male 936 904 1840
Female 224 236 460
Unknown 3 2 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1163 participants 1142 participants 2305 participants
North America 546 573 1119
Europe 567 527 1094
Argentina 50 42 92
1.Primary Outcome
Title Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Hide Description The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis: all enrolled patients were analyzed.
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient-years
7.93 7.47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.
Method Regression, Cox
Comments Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.79 to 1.10
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
2.Secondary Outcome
Title Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Hide Description

The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.

Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.

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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis: all enrolled patients were analyzed.
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient-years
12.15 12.70
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments Secondary null hypothesis was tested at two-tailed alpha = 0.05.
Method Regression, Cox
Comments Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.93 to 1.23
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
3.Other Pre-specified Outcome
Title Event Rate Per 100 Patient-years for Ischemic Stroke
Hide Description Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: rate per 100 patient years
1.36 0.72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.33 to 0.82
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
4.Other Pre-specified Outcome
Title Event Rate Per 100 Patient-years for Intracerebral Hemorrhage
Hide Description Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: rate per 100 patient years
0.05 0.12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.22
Confidence Interval 95%
0.43 to 11.66
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Event Rate Per 100 Patient-years for Death
Hide Description Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of death component of primary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient-years
6.52 6.63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.85 to 1.20
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
6.Other Pre-specified Outcome
Title Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome
Hide Description Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
0.87 0.80
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.58 to 1.64
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
7.Other Pre-specified Outcome
Title Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.
Hide Description Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat.
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
5.67 6.79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.998 to 1.47
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome
Hide Description Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
Time Frame From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat.
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
1.14 0.57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.32 to 0.96
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome
Hide Description Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
0.06 0.11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
0.32 to 9.88
Estimation Comments Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.
10.Other Pre-specified Outcome
Title Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome
Hide Description Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization to date of death component of secondary composite outcome, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
4.41 4.43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Regression, Cox
Comments Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval 95%
0.81 to 1.30
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Rate Per 100 Patient Years of Major Hemorrhage
Hide Description Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
Time Frame From date of randomization until end of scheduled follow-up, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient years
0.87 1.78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 2.05
Confidence Interval (2-Sided) 95%
1.36 to 3.12
Estimation Comments The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.
12.Other Pre-specified Outcome
Title Rate Per 100 Patient-years of Minor Hemorrhage.
Hide Description Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
Time Frame From date of randomization until the end of scheduled follow-up, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description:
Aspirin : 325 mg per day
Warfarin : INR 2.5-3.0; target INR 2.75
Overall Number of Participants Analyzed 1163 1142
Measure Type: Number
Unit of Measure: events per 100 patient-years
7.34 11.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.56
Confidence Interval 95%
1.34 to 1.81
Estimation Comments Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Warfarin
Hide Arm/Group Description Aspirin : 325 mg per day Warfarin : INR 2.5-3.0; target INR 2.75
All-Cause Mortality
Aspirin Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   617/1163 (53.05%)      632/1142 (55.34%)    
Blood and lymphatic system disorders     
Blood dyscrasia   3/1163 (0.26%)  3 4/1142 (0.35%)  4
BLOOD/BONE MARROW: Other   1/1163 (0.09%)  1 3/1142 (0.26%)  4
Thrombocytopenia/Anemia/Leukopenia   1/1163 (0.09%)  1 12/1142 (1.05%)  12
Hemorrhage/Bleeding   0/1163 (0.00%)  0 1/1142 (0.09%)  1
LYMPHATICS: Other   1/1163 (0.09%)  1 0/1142 (0.00%)  0
Peripheral edema   4/1163 (0.34%)  4 4/1142 (0.35%)  4
Cardiac disorders     
Atrial fibrillation/Atrial flutter/Supraventricular tachycardia   56/1163 (4.82%)  67 35/1142 (3.06%)  45
Bradycardia   6/1163 (0.52%)  6 6/1142 (0.53%)  6
CARDIAC ARRHYTHMIA: Other   7/1163 (0.60%)  7 3/1142 (0.26%)  3
Ventricular fibrillation   7/1163 (0.60%)  8 15/1142 (1.31%)  17
Ventricular tachycardia   24/1163 (2.06%)  33 39/1142 (3.42%)  46
Acute cardiac failure/CHF/Pulmonary edema   209/1163 (17.97%)  432 243/1142 (21.28%)  506
AICD firing/discharge   16/1163 (1.38%)  21 20/1142 (1.75%)  21
Angina/Chest pain   70/1163 (6.02%)  105 88/1142 (7.71%)  148
CARDIAC GENERAL: Other   16/1163 (1.38%)  18 16/1142 (1.40%)  19
Malignant hypertension   3/1163 (0.26%)  3 7/1142 (0.61%)  7
Myocardial infarction/Acute Coronary Syndrome   48/1163 (4.13%)  60 50/1142 (4.38%)  59
Pulmonary embolism   6/1163 (0.52%)  6 5/1142 (0.44%)  5
Endocrine disorders     
Diabetes mellitus and its complications   26/1163 (2.24%)  35 22/1142 (1.93%)  35
ENDOCRINE: Other   2/1163 (0.17%)  2 1/1142 (0.09%)  1
Eye disorders     
OCULAR/VISUAL: Other   5/1163 (0.43%)  7 3/1142 (0.26%)  5
Gastrointestinal disorders     
Gastrointestinal disturbance/Diarrhea/Jaundice/Nausea/Stomach pain/Etc.   54/1163 (4.64%)  70 66/1142 (5.78%)  82
GASTROINTESTINAL: Other   25/1163 (2.15%)  31 17/1142 (1.49%)  18
General disorders     
ALLERGY/IMMUNOLOGY: Other   1/1163 (0.09%)  1 1/1142 (0.09%)  1
Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash   4/1163 (0.34%)  4 2/1142 (0.18%)  2
CONSTITUTIONAL SYMPTOMS: Other   7/1163 (0.60%)  7 1/1142 (0.09%)  1
Drug abuse   3/1163 (0.26%)  3 1/1142 (0.09%)  1
OTHER: Other   19/1163 (1.63%)  23 32/1142 (2.80%)  33
Pregnancy   0/1163 (0.00%)  0 1/1142 (0.09%)  1
Suicide attempt/Psychiatric disorder   16/1163 (1.38%)  16 10/1142 (0.88%)  10
PAIN: Other   14/1163 (1.20%)  15 13/1142 (1.14%)  20
Hepatobiliary disorders     
Acute hepatic failure   3/1163 (0.26%)  3 3/1142 (0.26%)  3
HEPATOBILIARY/PANCREAS: Other   3/1163 (0.26%)  3 5/1142 (0.44%)  7
Infections and infestations     
Infection/Sepsis/Fever   66/1163 (5.67%)  79 79/1142 (6.92%)  97
Metabolism and nutrition disorders     
Metabolic disturbance/Gout   14/1163 (1.20%)  15 16/1142 (1.40%)  17
METABOLIC/LABORATORY: Other   12/1163 (1.03%)  14 10/1142 (0.88%)  11
Musculoskeletal and connective tissue disorders     
MUSCULOSKELETAL/SOFT TISSUE: Other   39/1163 (3.35%)  43 29/1142 (2.54%)  32
Visceral necrosis   0/1163 (0.00%)  0 4/1142 (0.35%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MALIGNANCY: Other   22/1163 (1.89%)  24 20/1142 (1.75%)  24
Nervous system disorders     
Convulsions/Seizures   6/1163 (0.52%)  6 5/1142 (0.44%)  10
NEUROLOGY: Other   8/1163 (0.69%)  8 7/1142 (0.61%)  7
Stroke or TIA   13/1163 (1.12%)  16 15/1142 (1.31%)  16
Syncope/Pre-syncope   41/1163 (3.53%)  48 68/1142 (5.95%)  83
Renal and urinary disorders     
Acute renal failure/Proteinuria   28/1163 (2.41%)  32 33/1142 (2.89%)  36
RENAL/GENITOURINARY: Other   7/1163 (0.60%)  7 7/1142 (0.61%)  7
Reproductive system and breast disorders     
SEXUAL/REPRODUCTIVE FUNCTION: Other   2/1163 (0.17%)  2 6/1142 (0.53%)  6
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   7/1163 (0.60%)  8 9/1142 (0.79%)  9
Pulmonary disease/Pneumonia/Bronchitis/Asthma/Breathing difficulties   87/1163 (7.48%)  133 79/1142 (6.92%)  100
PULMONARY/UPPER RESPIRATORY: Other   7/1163 (0.60%)  7 3/1142 (0.26%)  3
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN: Other   1/1163 (0.09%)  1 0/1142 (0.00%)  0
Grade 4 dermatologic manifestations   1/1163 (0.09%)  2 1/1142 (0.09%)  1
Surgical and medical procedures     
"Cardiac device implantation (pacemaker, defibrillator, etc.)"   123/1163 (10.58%)  133 109/1142 (9.54%)  118
"Cardiac procedure (stent, catheterization, EP study, ablation, etc.)"   62/1163 (5.33%)  76 66/1142 (5.78%)  82
Cardiac surgery   28/1163 (2.41%)  28 23/1142 (2.01%)  25
Non-cardiac surgery/Diagnostic surgery   75/1163 (6.45%)  102 57/1142 (4.99%)  67
SURGERY/INTRA-OPERATIVE INJURY: Other   4/1163 (0.34%)  4 8/1142 (0.70%)  8
Vascular disorders     
Systemic embolism   3/1163 (0.26%)  3 5/1142 (0.44%)  5
VASCULAR: Other   16/1163 (1.38%)  17 13/1142 (1.14%)  13
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   749/1163 (64.40%)      799/1142 (69.96%)    
General disorders     
All non-serious adverse events *  749/1163 (64.40%)  4483 799/1142 (69.96%)  4895
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. J.L.P. (Seamus) Thompson
Organization: Columbia University
Phone: 212-342-1252
EMail: jlt12@columbia.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shunichi Homma, Columbia University
ClinicalTrials.gov Identifier: NCT00041938     History of Changes
Other Study ID Numbers: AAAC1093
U01NS039143-01 ( U.S. NIH Grant/Contract )
R01NS39154
CRC
First Submitted: July 19, 2002
First Posted: July 22, 2002
Results First Submitted: January 3, 2013
Results First Posted: May 14, 2013
Last Update Posted: September 5, 2014