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Vitamin Therapy for Prevention of Stroke

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ClinicalTrials.gov Identifier: NCT00004734
Recruitment Status : Completed
First Posted : February 28, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Cerebral Infarction Myocardial Infarction Drug: pyridoxine Drug: cyanocobalamin Drug: folic acid multivitamin Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Vitamin Intervention for Stroke Prevention
Study Start Date : September 1996
Study Completion Date : February 2004
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Conditions preventing reliable participation in study: refractory depression, severe cognitive impairment, alcoholism, other substance abuse
  • Medications given within last 30 days that affect homocysteine: methotrexate, tamoxifen, L-dopa, phenytoin, or bile acid sequestrants that can decrease folate levels
  • Women of childbearing potential
  • Patients receiving active intervention in another trial
  • Patients on multi-vitamins, single B6, or folic acid, unless willing to discontinue and take study supplement
  • Any surgical procedure, invasive cardiac instrumentation, endarterectomy, stent placement, thrombectomy or other endovascular treatment of abnormal carotid artery performed within 30 days prior to randomization or scheduled within 30 days after randomization
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004734


Locations
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United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157-1068
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: James F. Toole, M.D. Wake Forest University
More Information
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ClinicalTrials.gov Identifier: NCT00004734    
Other Study ID Numbers: R01NS034447 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
cerebral infarction
homocysteine
vitamin
folic acid
 pyridoxine
vitamin B6
cyanocobalamin
vitamin B12
multivitamin
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Myocardial Infarction
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Brain Infarction
Brain Ischemia
Folic Acid
Pyridoxine
Vitamin B 12
Hydroxocobalamin
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs