Vitamin Intervention for Stroke Prevention
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Locations
- 1
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may result in difficulty with feeling, speech, muscle strength or coordination, movement, thinking, or other brain functions. Having a stroke increases the risk of another stroke occurring in the future. Higher blood levels of a natural chemical known as homocysteine may contribute to hardening of the arteries in the brain or heart and increase the risk of stroke or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may lower blood levels of homocysteine and reduce the risk of having another stroke or a heart attack.
Detailed Description
The incidence of a second stroke in patients who have had a first stroke is between 7 and 10 percent per year. Myocardial infarction (heart attack) as a complication of stroke adds to stroke death and disability. Because homocysteine may be a major contributor to stroke, its reduction by appropriate intervention with vitamin supplements could reduce the impact of recurrent stroke, myocardial infarction, and vascular death. The purpose of this trial is to determine whether a multivitamin containing high-dose folic acid, pyridoxine, and cyanocobalamin, in addition to best medical/surgical management and risk factor modification, reduces the recurrence of stroke or occurrence of myocardial infarction in stroke patients with elevated homocysteine levels.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any stroke (non-disabling cerebral infarction, NDCI) \< 120 days prior to randomization
- •Symptoms lasting \> 24 hrs, or if \< 24 hrs, CT or MRI shows new infarction at expected site
- •Modified Rankin score \< 3
- •Homocysteine level \> the 25th percentile, ie, 9.5 mol/L for men, and 8.5 mol/L for women
- •Patient compliance with multivitamin during run-in phase \> 75%
Exclusion Criteria
- •Stroke due to: intracranial hemorrhage, dissection of a cervico-cephalic artery, veno-occlusive disease, drug abuse, vasculitis
- •CT or MRI shows lesion other than infarction as cause of syndrome
- •Modified Rankin score of 4 or 5 at eligibility
- •Presence of potential sources of cardiogenic emboli: atrial fibrillation, prosthetic cardiac valve, intracardiac thrombus or neoplasm, valvular vegetation
- •Neurologic illness other than stroke that would prevent proper evaluation of recurrent stroke
- •Illness that limits life expectancy to \< 2 years
- •Severe congestive heart failure
- •Renal insufficiency requiring dialysis
- •Untreated B12 deficiency or untreated pernicious anemia
- •Uncontrolled hypertension (systolic \>185 mm/Hg or diastolic \>105 mm/Hg on two readings separated by 5 min.) at eligibility
Outcomes
Primary Outcomes
Not specified