Warfarin Versus Aspirin in Reduced Cardiac Ejection Fract... | NCT00041938

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Description Module

Label	Type	Description	Intervention Names
aspirin	Active Comparator	Aspirin: 325 mg per day	Drug: aspirin
warfarin	Active Comparator	Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75	Drug: Warfarin

Name	Type	Description	Arm Group Labels	Other Names
aspirin	Drug	325 mg per day	aspirin
Warfarin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.	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.

Other Outcomes

Measure	Description	Time Frame
Event Rate Per 100 Patient-years for Ischemic Stroke	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
Modified Rankin score <=4.
Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.

Exclusion Criteria

The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
Cyanotic congenital heart disease, Eisenmenger's syndrome.
Decompensated heart failure.
Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
Comorbid conditions that may limit survival to less than five years.
Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
Enrollment in another study that would conflict with WARCEF.
Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
Person under 18 years of age.

Name	Affiliation	Role
Shunichi Homma, M.D.	Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine	Principal Investigator
Seamus Thompson, PhD	Statistical PI: Clinical Professor of Biostatistics and Neurology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Southern Arizona Veterans Affairs Medical Center		Tucson	Arizona		United States
University of Arizona Health Sciences Center

PubMed Identifier	Type	Citation	Retractions
38393500	Derived	Romiti GF, Nabrdalik K, Corica B, Bucci T, Proietti M, Qian M, Chen Y, Thompson JLP, Homma S, Lip GYH; WARCEF Investigators. Diabetes mellitus in patients with heart failure and reduced ejection fraction: a post hoc analysis from the WARCEF trial. Intern Emerg Med. 2024 Jun;19(4):931-939. doi: 10.1007/s11739-024-03544-4. Epub 2024 Feb 23.
38205865	Derived	Corica B, Romiti GF, Simoni AH, Mei DA, Bucci T, Thompson JLP, Qian M, Homma S, Proietti M, Lip GYH; WARCEF Investigators. Educational status affects prognosis of patients with heart failure with reduced ejection fraction: A post-hoc analysis from the WARCEF trial. Eur J Clin Invest. 2024 May;54(5):e14152. doi: 10.1111/eci.14152. Epub 2024 Jan 11.

ID	Title	Description
FG000	Aspirin	Aspirin : 325 mg per day
FG001	Warfarin	Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death

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.

Intent-to-treat analysis: all enrolled patients were analyzed.

Posted

Number

events per 100 patient-years

From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG0001163 OG0011142

Title

Denominators

Categories

Title	Measurements
	OG0007.93 OG0017.47

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	Regression, Cox	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.	0.40	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.	Hazard Ratio (HR)	0.93			2-Sided	95	0.79

Secondary

Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.

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.

Intent-to-treat analysis: all enrolled patients were analyzed.

Posted

Number

events per 100 patient-years

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.

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants

Other Pre-specified

Event Rate Per 100 Patient-years for Ischemic Stroke

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.

Intent-to-treat

Posted

Number

rate per 100 patient years

From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient-years for Intracerebral Hemorrhage

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.

Intent-to-treat

Posted

Number

rate per 100 patient years

From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient-years for Death

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.

Intent-to-treat

Posted

Number

events per 100 patient-years

From date of randomization to date of death component of primary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome

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.

Intent-to-treat

Posted

Number

events per 100 patient years

From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.

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.

Intent-to-treat.

Posted

Number

events per 100 patient years

From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome

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.

Intent-to-treat.

Posted

Number

events per 100 patient years

From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants

Other Pre-specified

Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome

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.

Intent-to-treat

Posted

Number

events per 100 patient years

From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome

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.

Intent-to-treat

Posted

Number

events per 100 patient years

From date of randomization to date of death component of secondary composite outcome, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Other Pre-specified

Rate Per 100 Patient Years of Major Hemorrhage

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.

Intent-to-treat

Posted

Number

events per 100 patient years

From date of randomization until end of scheduled follow-up, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants

Other Pre-specified

Rate Per 100 Patient-years of Minor Hemorrhage.

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.

Intent-to-treat

Posted

Number

events per 100 patient-years

From date of randomization until the end of scheduled follow-up, up to 6 years

ID	Title	Description
OG000	Aspirin	Aspirin : 325 mg per day
OG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ALLERGY/IMMUNOLOGY: Other	General disorders	Systematic Assessment	EG0001 events1 affected1,163 at risk EG0011 events1 affected1,142 at risk
Laryngeal edema/Allergic reaction/Anaphylaxis/Angioedema/Rash	General disorders	Systematic Assessment	EG0004 events4 affected1,163 at risk EG0012 events2 affected1,142 at risk
Blood dyscrasia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0014 events4 affected1,142 at risk
BLOOD/BONE MARROW: Other	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,163 at risk EG0014 events3 affected1,142 at risk
Thrombocytopenia/Anemia/Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,163 at risk EG00112 events12 affected1,142 at risk
Atrial fibrillation/Atrial flutter/Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG00067 events56 affected1,163 at risk EG00145 events35 affected1,142 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0006 events6 affected1,163 at risk EG0016 events6 affected1,142 at risk
CARDIAC ARRHYTHMIA: Other	Cardiac disorders	Systematic Assessment	EG0007 events7 affected1,163 at risk EG0013 events3 affected1,142 at risk
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0008 events7 affected1,163 at risk EG00117 events15 affected1,142 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG00033 events24 affected1,163 at risk EG00146 events39 affected1,142 at risk
Acute cardiac failure/CHF/Pulmonary edema	Cardiac disorders	Systematic Assessment	EG000432 events209 affected1,163 at risk EG001506 events243 affected1,142 at risk
AICD firing/discharge	Cardiac disorders	Systematic Assessment	EG00021 events16 affected1,163 at risk EG00121 events20 affected1,142 at risk
Angina/Chest pain	Cardiac disorders	Systematic Assessment	EG000105 events70 affected1,163 at risk EG001148 events88 affected1,142 at risk
CARDIAC GENERAL: Other	Cardiac disorders	Systematic Assessment	EG00018 events16 affected1,163 at risk EG00119 events16 affected1,142 at risk
Malignant hypertension	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0017 events7 affected1,142 at risk
Myocardial infarction/Acute Coronary Syndrome	Cardiac disorders	Systematic Assessment	EG00060 events48 affected1,163 at risk EG00159 events50 affected1,142 at risk
Pulmonary embolism	Cardiac disorders	Systematic Assessment	EG0006 events6 affected1,163 at risk EG0015 events5 affected1,142 at risk
CONSTITUTIONAL SYMPTOMS: Other	General disorders	Systematic Assessment	EG0007 events7 affected1,163 at risk EG0011 events1 affected1,142 at risk
DERMATOLOGY/SKIN: Other	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,163 at risk EG0010 events0 affected1,142 at risk
Grade 4 dermatologic manifestations	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events1 affected1,163 at risk EG0011 events1 affected1,142 at risk
Diabetes mellitus and its complications	Endocrine disorders	Systematic Assessment	EG00035 events26 affected1,163 at risk EG00135 events22 affected1,142 at risk
ENDOCRINE: Other	Endocrine disorders	Systematic Assessment	EG0002 events2 affected1,163 at risk EG0011 events1 affected1,142 at risk
Gastrointestinal disturbance/Diarrhea/Jaundice/Nausea/Stomach pain/Etc.	Gastrointestinal disorders	Systematic Assessment	EG00070 events54 affected1,163 at risk EG00182 events66 affected1,142 at risk
GASTROINTESTINAL: Other	Gastrointestinal disorders	Systematic Assessment	EG00031 events25 affected1,163 at risk EG00118 events17 affected1,142 at risk
Hemorrhage/Bleeding	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,163 at risk EG0011 events1 affected1,142 at risk
Acute hepatic failure	Hepatobiliary disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0013 events3 affected1,142 at risk
HEPATOBILIARY/PANCREAS: Other	Hepatobiliary disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0017 events5 affected1,142 at risk
Infection/Sepsis/Fever	Infections and infestations	Systematic Assessment	EG00079 events66 affected1,163 at risk EG00197 events79 affected1,142 at risk
LYMPHATICS: Other	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,163 at risk EG0010 events0 affected1,142 at risk
Peripheral edema	Blood and lymphatic system disorders	Systematic Assessment	EG0004 events4 affected1,163 at risk EG0014 events4 affected1,142 at risk
MALIGNANCY: Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG00024 events22 affected1,163 at risk EG00124 events20 affected1,142 at risk
Metabolic disturbance/Gout	Metabolism and nutrition disorders	Systematic Assessment	EG00015 events14 affected1,163 at risk EG00117 events16 affected1,142 at risk
METABOLIC/LABORATORY: Other	Metabolism and nutrition disorders	Systematic Assessment	EG00014 events12 affected1,163 at risk EG00111 events10 affected1,142 at risk
MUSCULOSKELETAL/SOFT TISSUE: Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00043 events39 affected1,163 at risk EG00132 events29 affected1,142 at risk
Visceral necrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,163 at risk EG0014 events4 affected1,142 at risk
Convulsions/Seizures	Nervous system disorders	Systematic Assessment	EG0006 events6 affected1,163 at risk EG00110 events5 affected1,142 at risk
NEUROLOGY: Other	Nervous system disorders	Systematic Assessment	EG0008 events8 affected1,163 at risk EG0017 events7 affected1,142 at risk
Stroke or TIA	Nervous system disorders	Systematic Assessment	EG00016 events13 affected1,163 at risk EG00116 events15 affected1,142 at risk
Syncope/Pre-syncope	Nervous system disorders	Systematic Assessment	EG00048 events41 affected1,163 at risk EG00183 events68 affected1,142 at risk
OCULAR/VISUAL: Other	Eye disorders	Systematic Assessment	EG0007 events5 affected1,163 at risk EG0015 events3 affected1,142 at risk
Drug abuse	General disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0011 events1 affected1,142 at risk
OTHER: Other	General disorders	Systematic Assessment	EG00023 events19 affected1,163 at risk EG00133 events32 affected1,142 at risk
Pregnancy	General disorders	Systematic Assessment	EG0000 events0 affected1,163 at risk EG0011 events1 affected1,142 at risk
Suicide attempt/Psychiatric disorder	General disorders	Systematic Assessment	EG00016 events16 affected1,163 at risk EG00110 events10 affected1,142 at risk
PAIN: Other	General disorders	Systematic Assessment	EG00015 events14 affected1,163 at risk EG00120 events13 affected1,142 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events7 affected1,163 at risk EG0019 events9 affected1,142 at risk
Pulmonary disease/Pneumonia/Bronchitis/Asthma/Breathing difficulties	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG000133 events87 affected1,163 at risk EG001100 events79 affected1,142 at risk
PULMONARY/UPPER RESPIRATORY: Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 events7 affected1,163 at risk EG0013 events3 affected1,142 at risk
Acute renal failure/Proteinuria	Renal and urinary disorders	Systematic Assessment	EG00032 events28 affected1,163 at risk EG00136 events33 affected1,142 at risk
RENAL/GENITOURINARY: Other	Renal and urinary disorders	Systematic Assessment	EG0007 events7 affected1,163 at risk EG0017 events7 affected1,142 at risk
SEXUAL/REPRODUCTIVE FUNCTION: Other	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected1,163 at risk EG0016 events6 affected1,142 at risk
"Cardiac device implantation (pacemaker, defibrillator, etc.)"	Surgical and medical procedures	Systematic Assessment	EG000133 events123 affected1,163 at risk EG001118 events109 affected1,142 at risk
"Cardiac procedure (stent, catheterization, EP study, ablation, etc.)"	Surgical and medical procedures	Systematic Assessment	EG00076 events62 affected1,163 at risk EG00182 events66 affected1,142 at risk
Cardiac surgery	Surgical and medical procedures	Systematic Assessment	EG00028 events28 affected1,163 at risk EG00125 events23 affected1,142 at risk
Non-cardiac surgery/Diagnostic surgery	Surgical and medical procedures	Systematic Assessment	EG000102 events75 affected1,163 at risk EG00167 events57 affected1,142 at risk
SURGERY/INTRA-OPERATIVE INJURY: Other	Surgical and medical procedures	Systematic Assessment	EG0004 events4 affected1,163 at risk EG0018 events8 affected1,142 at risk
Systemic embolism	Vascular disorders	Systematic Assessment	EG0003 events3 affected1,163 at risk EG0015 events5 affected1,142 at risk
VASCULAR: Other	Vascular disorders	Systematic Assessment	EG00017 events16 affected1,163 at risk EG00113 events13 affected1,142 at risk

ID	Type	Link
U01NS039143-01	U.S. NIH Grant/Contract	View source
R01NS39154
CRC

ID	Term
D006331	Heart Diseases
D020521	Stroke
D017202	Myocardial Ischemia
D009203	Myocardial Infarction
D001281	Atrial Fibrillation
D006333	Heart Failure

ID	Term
D002318	Cardiovascular Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D001145	Arrhythmias, Cardiac

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Aspirin	Aspirin : 325 mg per day
BG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aspirin	Aspirin : 325 mg per day			617	1,163	749	1,163
EG001	Warfarin	Warfarin : INR 2.5-3.0; target INR 2.75			632	1,142	799	1,142