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Aspirin Or Warfarin To Prevent Stroke

Primary Purpose

Stroke, Cerebral Infarction, Atherosclerosis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Warfarin
Aspirin
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, cerebral infarction, warfarin, coumadin, aspirin, ASA, acetysalicylic acid, atherosclerosis, stenosis, intracranial, artery, arteries, transient ischemic attack, TIA, minorities

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: TIA or non-severe stroke within 90 days prior to randomization (including day 90) Modified Rankin score of < 3 High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90) TIA or stroke is attributed to high grade intracranial stenosis Age > 40 years 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 Exclusion Criteria: Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms) Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, 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 (SGOT > 3x normal*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine > 3.0* Indication for intravenous heparin beyond randomization A severe neurological deficit that renders the patient incapable of living independently Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably Co-morbid conditions that may limit survival to less than five years Pregnancy or female in age range of childbearing potential who is not using contraception Enrollment in another study that would conflict with the current study Excluded because difficult to measure percent stenosis of these small arteries, lesions are uncommon, and prognosis of patients - With these lesions is unknown * on most recent test done within 90 days prior to randomization, including day 90

Sites / Locations

  • Emory University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 25, 2000
Last Updated
June 5, 2006
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00004728
Brief Title
Aspirin Or Warfarin To Prevent Stroke
Official Title
Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis.
Detailed Description
Prevention of stroke in patients with narrowing of one of the arteries in the brain typically consists of using medications to prevent blood clots from forming. Currently, the best medication to use in this situation is unknown. The purpose of this study is to compare the effectiveness of two different medications, warfarin or aspirin, for the prevention of stroke due to narrowing of one of the large arteries in the brain. Patients must have experienced a recent transient ischemic attack (TIA) or mild stroke. Stroke of this type is thought to occur more often in minorities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Infarction, Atherosclerosis, Constriction, Pathologic
Keywords
stroke, cerebral infarction, warfarin, coumadin, aspirin, ASA, acetysalicylic acid, atherosclerosis, stenosis, intracranial, artery, arteries, transient ischemic attack, TIA, minorities

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Type
Drug
Intervention Name(s)
Aspirin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TIA or non-severe stroke within 90 days prior to randomization (including day 90) Modified Rankin score of < 3 High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90) TIA or stroke is attributed to high grade intracranial stenosis Age > 40 years 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 Exclusion Criteria: Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms) Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, 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 (SGOT > 3x normal*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine > 3.0* Indication for intravenous heparin beyond randomization A severe neurological deficit that renders the patient incapable of living independently Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably Co-morbid conditions that may limit survival to less than five years Pregnancy or female in age range of childbearing potential who is not using contraception Enrollment in another study that would conflict with the current study Excluded because difficult to measure percent stenosis of these small arteries, lesions are uncommon, and prognosis of patients - With these lesions is unknown * on most recent test done within 90 days prior to randomization, including day 90
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Chimowitz
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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