Aspirin Or Warfarin To Prevent Stroke

This study has been terminated.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00004728
First received: February 25, 2000
Last updated: June 5, 2006
Last verified: June 2006
  Purpose

The purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis.


Condition Intervention Phase
Stroke
Cerebral Infarction
Atherosclerosis
Constriction, Pathologic
Drug: Warfarin
Drug: Aspirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study

Resource links provided by NLM:


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

Estimated Study Completion Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004728

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Investigators
Principal Investigator: Marc Chimowitz Emory University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004728     History of Changes
Other Study ID Numbers: R01NS36643
Study First Received: February 25, 2000
Last Updated: June 5, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
cerebral infarction
warfarin
coumadin
aspirin
ASA
acetysalicylic acid
atherosclerosis
stenosis
intracranial
artery
arteries
transient ischemic attack
TIA
minorities

Additional relevant MeSH terms:
Atherosclerosis
Cerebral Infarction
Stroke
Constriction, Pathologic
Infarction
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014