Suspended
Comparing Warfarin and Aspirin for Stroke Prevention in Patients with Intracranial Artery Narrowing
What is being tested
Warfarin
+ Aspirin
Drug
Who is being recruted
Arterial Occlusive Diseases+18
+ Arteriosclerosis
+ Brain Diseases
Over 40 Years
+19 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 3
Interventional
Summary
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 6, 2006
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 6, 2006
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arterial Occlusive DiseasesArteriosclerosisBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesBrain IschemiaCerebrovascular DisordersInfarctionIschemiaNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesBrain InfarctionPathological Conditions, AnatomicalCerebral InfarctionIschemic Attack, TransientConstriction, PathologicStrokeAtherosclerosis
Criteria
7 inclusion criteria required to participate
Age > 40 years
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)
Modified Rankin score of < 3
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
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12 exclusion criteria prevent from participating
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*
A severe neurological deficit that renders the patient incapable of living independently
Co-morbid conditions that may limit survival to less than five years
Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center