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Warfarin Versus Aspirin Recurrent Stroke Study
This study has been completed.
First Received: November 20, 2001   Last Updated: June 23, 2005   History of Changes
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00027066
  Purpose

The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.


Condition Intervention Phase
Stroke
Drug: aspirin
Drug: warfarin
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Estimated Enrollment: 2206
Detailed Description:

This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.

To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.

This study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.

  Eligibility

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027066

Locations
United States, New York
Columbia University Health Sciences
New York, New York, United States
Sponsors and Collaborators
Investigators
Principal Investigator: J. P. Mohr, M.D. Columbia University Health Sciences
  More Information

Additional Information:
No publications provided

Study ID Numbers: R01NS28371
Study First Received: November 20, 2001
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00027066     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
aspirin
warfarin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Anticoagulants
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Warfarin
Pharmacologic Actions
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Brain Infarction
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009