Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study
Aspirin Or Warfarin To Prevent Stroke
Sponsors
Source
National Institute of Neurological Disorders and Stroke (NINDS)
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.
Overall Status
Terminated
Start Date
N/A
Completion Date
2003-07-01
Primary Completion Date
N/A
Phase
Phase 3
Study Type
Interventional
Conditions
Intervention
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
Gender
All
Minimum Age
40 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
Marc Chimowitz |
Principal Investigator |
Emory University |
Location
Facility |
Emory University Atlanta Georgia 30322 United States |
Location Countries
Country
United States
Verification Date
2006-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
stroke
, cerebral infarction
, warfarin
, coumadin
, aspirin
, ASA
, acetysalicylic acid
, atherosclerosis
, stenosis
, intracranial
, artery
, arteries
, transient ischemic attack
, TIA
, minorities 















Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Aspirin
Warfarin
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Primary Purpose
Prevention
Masking
Double
Study First Submitted
February 25, 2000
Study First Submitted Qc
February 25, 2000
Study First Posted
February 28, 2000
Last Update Submitted
June 5, 2006
Last Update Submitted Qc
June 5, 2006
Last Update Posted
June 6, 2006
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.