Vitamin Therapy for Prevention of Stroke - Full Text View

Purpose

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	Intervention	Phase
Stroke Cerebral Infarction Myocardial Infarction	Drug: pyridoxine Drug: cyanocobalamin Drug: folic acid multivitamin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Vitamin Intervention for Stroke Prevention

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


Study Start Date:	September 1996
Estimated Study Completion Date:	February 2004

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.

Eligibility


Ages Eligible for Study:	35 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004734

Locations


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


Principal Investigator:	James F. Toole, M.D.	Wake Forest University

More Information


ClinicalTrials.gov Identifier:	NCT00004734 History of Changes
Other Study ID Numbers:	R01NS034447 ( US NIH Grant/Contract Award Number )
Study First Received:	February 25, 2000
Last Updated:	June 23, 2005

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:


Stroke Infarction Myocardial Infarction Cerebral 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 Vitamins Folic Acid Vitamin B 12 Hydroxocobalamin Pyridoxine Pyridoxal Vitamin B 6 Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Hematinics

ClinicalTrials.gov processed this record on June 23, 2017