Trial Outcomes & Findings for Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (NCT NCT00041938)
NCT ID: NCT00041938
Last Updated: 2014-09-05
Results Overview
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.
COMPLETED
PHASE3
2305 participants
From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years
2014-09-05
Participant Flow
Recruited 2305 patients at 176 sites in 11 countries, between 10/1/2002 and 1/31/2010.
Intent-to-treat trial - all randomized patients followed and analyzed.
Participant milestones
| Measure |
Aspirin
Aspirin : 325 mg per day
|
Warfarin
Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Overall Study
STARTED
|
1163
|
1142
|
|
Overall Study
Completed Follow-up
|
761
|
745
|
|
Overall Study
Primary Endpoint
|
320
|
302
|
|
Overall Study
Only Vital Status Known
|
44
|
46
|
|
Overall Study
Lost to Follow-up
|
18
|
17
|
|
Overall Study
Withdrew Consent
|
20
|
14
|
|
Overall Study
COMPLETED
|
1125
|
1111
|
|
Overall Study
NOT COMPLETED
|
38
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
Baseline characteristics by cohort
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
Total
n=2305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
732 Participants
n=5 Participants
|
706 Participants
n=7 Participants
|
1438 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
431 Participants
n=5 Participants
|
436 Participants
n=7 Participants
|
867 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
61 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
936 participants
n=5 Participants
|
904 participants
n=7 Participants
|
1840 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
224 participants
n=5 Participants
|
236 participants
n=7 Participants
|
460 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
546 participants
n=5 Participants
|
573 participants
n=7 Participants
|
1119 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
567 participants
n=5 Participants
|
527 participants
n=7 Participants
|
1094 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
50 participants
n=5 Participants
|
42 participants
n=7 Participants
|
92 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 yearsPopulation: Intent-to-treat analysis: all enrolled patients were analyzed.
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
|
7.93 events per 100 patient-years
|
7.47 events per 100 patient-years
|
SECONDARY outcome
Timeframe: 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.Population: Intent-to-treat analysis: all enrolled patients were analyzed.
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
|
12.15 events per 100 patient-years
|
12.70 events per 100 patient-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient-years for Ischemic Stroke
|
1.36 rate per 100 patient years
|
0.72 rate per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient-years for Intracerebral Hemorrhage
|
0.05 rate per 100 patient years
|
0.12 rate per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of death component of primary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient-years for Death
|
6.52 events per 100 patient-years
|
6.63 events per 100 patient-years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome
|
0.87 events per 100 patient years
|
0.80 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 yearsPopulation: Intent-to-treat.
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.
|
5.67 events per 100 patient years
|
6.79 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 yearsPopulation: Intent-to-treat.
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome
|
1.14 events per 100 patient years
|
0.57 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome
|
0.06 events per 100 patient years
|
0.11 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization to date of death component of secondary composite outcome, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome
|
4.41 events per 100 patient years
|
4.43 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until end of scheduled follow-up, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Rate Per 100 Patient Years of Major Hemorrhage
|
0.87 events per 100 patient years
|
1.78 events per 100 patient years
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until the end of scheduled follow-up, up to 6 yearsPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Aspirin
n=1163 Participants
Aspirin : 325 mg per day
|
Warfarin
n=1142 Participants
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
Rate Per 100 Patient-years of Minor Hemorrhage.
|
7.34 events per 100 patient-years
|
11.6 events per 100 patient-years
|
Adverse Events
Aspirin
Warfarin
Serious adverse events
| Measure |
Aspirin
n=1163 participants at risk
Aspirin : 325 mg per day
|
Warfarin
n=1142 participants at risk
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
General disorders
ALLERGY/IMMUNOLOGY: Other
|
0.09%
1/1163 • Number of events 1
|
0.09%
1/1142 • Number of events 1
|
|
General disorders
Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash
|
0.34%
4/1163 • Number of events 4
|
0.18%
2/1142 • Number of events 2
|
|
Blood and lymphatic system disorders
Blood dyscrasia
|
0.26%
3/1163 • Number of events 3
|
0.35%
4/1142 • Number of events 4
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW: Other
|
0.09%
1/1163 • Number of events 1
|
0.26%
3/1142 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia/Anemia/Leukopenia
|
0.09%
1/1163 • Number of events 1
|
1.1%
12/1142 • Number of events 12
|
|
Cardiac disorders
Atrial fibrillation/Atrial flutter/Supraventricular tachycardia
|
4.8%
56/1163 • Number of events 67
|
3.1%
35/1142 • Number of events 45
|
|
Cardiac disorders
Bradycardia
|
0.52%
6/1163 • Number of events 6
|
0.53%
6/1142 • Number of events 6
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA: Other
|
0.60%
7/1163 • Number of events 7
|
0.26%
3/1142 • Number of events 3
|
|
Cardiac disorders
Ventricular fibrillation
|
0.60%
7/1163 • Number of events 8
|
1.3%
15/1142 • Number of events 17
|
|
Cardiac disorders
Ventricular tachycardia
|
2.1%
24/1163 • Number of events 33
|
3.4%
39/1142 • Number of events 46
|
|
Cardiac disorders
Acute cardiac failure/CHF/Pulmonary edema
|
18.0%
209/1163 • Number of events 432
|
21.3%
243/1142 • Number of events 506
|
|
Cardiac disorders
AICD firing/discharge
|
1.4%
16/1163 • Number of events 21
|
1.8%
20/1142 • Number of events 21
|
|
Cardiac disorders
Angina/Chest pain
|
6.0%
70/1163 • Number of events 105
|
7.7%
88/1142 • Number of events 148
|
|
Cardiac disorders
CARDIAC GENERAL: Other
|
1.4%
16/1163 • Number of events 18
|
1.4%
16/1142 • Number of events 19
|
|
Cardiac disorders
Malignant hypertension
|
0.26%
3/1163 • Number of events 3
|
0.61%
7/1142 • Number of events 7
|
|
Cardiac disorders
Myocardial infarction/Acute Coronary Syndrome
|
4.1%
48/1163 • Number of events 60
|
4.4%
50/1142 • Number of events 59
|
|
Cardiac disorders
Pulmonary embolism
|
0.52%
6/1163 • Number of events 6
|
0.44%
5/1142 • Number of events 5
|
|
General disorders
CONSTITUTIONAL SYMPTOMS: Other
|
0.60%
7/1163 • Number of events 7
|
0.09%
1/1142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN: Other
|
0.09%
1/1163 • Number of events 1
|
0.00%
0/1142
|
|
Skin and subcutaneous tissue disorders
Grade 4 dermatologic manifestations
|
0.09%
1/1163 • Number of events 2
|
0.09%
1/1142 • Number of events 1
|
|
Endocrine disorders
Diabetes mellitus and its complications
|
2.2%
26/1163 • Number of events 35
|
1.9%
22/1142 • Number of events 35
|
|
Endocrine disorders
ENDOCRINE: Other
|
0.17%
2/1163 • Number of events 2
|
0.09%
1/1142 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disturbance/Diarrhea/Jaundice/Nausea/Stomach pain/Etc.
|
4.6%
54/1163 • Number of events 70
|
5.8%
66/1142 • Number of events 82
|
|
Gastrointestinal disorders
GASTROINTESTINAL: Other
|
2.1%
25/1163 • Number of events 31
|
1.5%
17/1142 • Number of events 18
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
0.00%
0/1163
|
0.09%
1/1142 • Number of events 1
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.26%
3/1163 • Number of events 3
|
0.26%
3/1142 • Number of events 3
|
|
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS: Other
|
0.26%
3/1163 • Number of events 3
|
0.44%
5/1142 • Number of events 7
|
|
Infections and infestations
Infection/Sepsis/Fever
|
5.7%
66/1163 • Number of events 79
|
6.9%
79/1142 • Number of events 97
|
|
Blood and lymphatic system disorders
LYMPHATICS: Other
|
0.09%
1/1163 • Number of events 1
|
0.00%
0/1142
|
|
Blood and lymphatic system disorders
Peripheral edema
|
0.34%
4/1163 • Number of events 4
|
0.35%
4/1142 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANCY: Other
|
1.9%
22/1163 • Number of events 24
|
1.8%
20/1142 • Number of events 24
|
|
Metabolism and nutrition disorders
Metabolic disturbance/Gout
|
1.2%
14/1163 • Number of events 15
|
1.4%
16/1142 • Number of events 17
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY: Other
|
1.0%
12/1163 • Number of events 14
|
0.88%
10/1142 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE: Other
|
3.4%
39/1163 • Number of events 43
|
2.5%
29/1142 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Visceral necrosis
|
0.00%
0/1163
|
0.35%
4/1142 • Number of events 4
|
|
Nervous system disorders
Convulsions/Seizures
|
0.52%
6/1163 • Number of events 6
|
0.44%
5/1142 • Number of events 10
|
|
Nervous system disorders
NEUROLOGY: Other
|
0.69%
8/1163 • Number of events 8
|
0.61%
7/1142 • Number of events 7
|
|
Nervous system disorders
Stroke or TIA
|
1.1%
13/1163 • Number of events 16
|
1.3%
15/1142 • Number of events 16
|
|
Nervous system disorders
Syncope/Pre-syncope
|
3.5%
41/1163 • Number of events 48
|
6.0%
68/1142 • Number of events 83
|
|
Eye disorders
OCULAR/VISUAL: Other
|
0.43%
5/1163 • Number of events 7
|
0.26%
3/1142 • Number of events 5
|
|
General disorders
Drug abuse
|
0.26%
3/1163 • Number of events 3
|
0.09%
1/1142 • Number of events 1
|
|
General disorders
OTHER: Other
|
1.6%
19/1163 • Number of events 23
|
2.8%
32/1142 • Number of events 33
|
|
General disorders
Pregnancy
|
0.00%
0/1163
|
0.09%
1/1142 • Number of events 1
|
|
General disorders
Suicide attempt/Psychiatric disorder
|
1.4%
16/1163 • Number of events 16
|
0.88%
10/1142 • Number of events 10
|
|
General disorders
PAIN: Other
|
1.2%
14/1163 • Number of events 15
|
1.1%
13/1142 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
7/1163 • Number of events 8
|
0.79%
9/1142 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary disease/Pneumonia/Bronchitis/Asthma/Breathing difficulties
|
7.5%
87/1163 • Number of events 133
|
6.9%
79/1142 • Number of events 100
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY: Other
|
0.60%
7/1163 • Number of events 7
|
0.26%
3/1142 • Number of events 3
|
|
Renal and urinary disorders
Acute renal failure/Proteinuria
|
2.4%
28/1163 • Number of events 32
|
2.9%
33/1142 • Number of events 36
|
|
Renal and urinary disorders
RENAL/GENITOURINARY: Other
|
0.60%
7/1163 • Number of events 7
|
0.61%
7/1142 • Number of events 7
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION: Other
|
0.17%
2/1163 • Number of events 2
|
0.53%
6/1142 • Number of events 6
|
|
Surgical and medical procedures
"Cardiac device implantation (pacemaker, defibrillator, etc.)"
|
10.6%
123/1163 • Number of events 133
|
9.5%
109/1142 • Number of events 118
|
|
Surgical and medical procedures
"Cardiac procedure (stent, catheterization, EP study, ablation, etc.)"
|
5.3%
62/1163 • Number of events 76
|
5.8%
66/1142 • Number of events 82
|
|
Surgical and medical procedures
Cardiac surgery
|
2.4%
28/1163 • Number of events 28
|
2.0%
23/1142 • Number of events 25
|
|
Surgical and medical procedures
Non-cardiac surgery/Diagnostic surgery
|
6.4%
75/1163 • Number of events 102
|
5.0%
57/1142 • Number of events 67
|
|
Surgical and medical procedures
SURGERY/INTRA-OPERATIVE INJURY: Other
|
0.34%
4/1163 • Number of events 4
|
0.70%
8/1142 • Number of events 8
|
|
Vascular disorders
Systemic embolism
|
0.26%
3/1163 • Number of events 3
|
0.44%
5/1142 • Number of events 5
|
|
Vascular disorders
VASCULAR: Other
|
1.4%
16/1163 • Number of events 17
|
1.1%
13/1142 • Number of events 13
|
Other adverse events
| Measure |
Aspirin
n=1163 participants at risk
Aspirin : 325 mg per day
|
Warfarin
n=1142 participants at risk
Warfarin : INR 2.5-3.0; target INR 2.75
|
|---|---|---|
|
General disorders
All non-serious adverse events
|
64.4%
749/1163 • Number of events 4483
|
70.0%
799/1142 • Number of events 4895
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place