Completed

Multivitamin Intervention for Reduced Stroke Recurrence and Myocardial Infarction in Stroke Patients with Elevated Homocysteine

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

pyridoxine

+ cyanocobalamin

+ folic acid multivitamin

Drug
Who is being recruted

Brain Diseases+15

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 35 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: September 1996
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00004734
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: June 24, 2005
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 35 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

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesBrain IschemiaCerebrovascular DisordersHeart DiseasesInfarctionIschemiaNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaBrain InfarctionCerebral InfarctionMyocardial InfarctionStroke

Criteria

5 inclusion criteria required to participate
Any stroke (non-disabling cerebral infarction, NDCI) < 120 days prior to randomization
Homocysteine level > the 25th percentile, ie, 9.5 mol/L for men, and 8.5 mol/L for women
Modified Rankin score < 3
Patient compliance with multivitamin during run-in phase > 75%
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16 exclusion criteria prevent from participating
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
CT or MRI shows lesion other than infarction as cause of syndrome
Conditions preventing reliable participation in study: refractory depression, severe cognitive impairment, alcoholism, other substance abuse
Illness that limits life expectancy to < 2 years
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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

Wake Forest University School of Medicine

Winston-Salem, United StatesOpen Wake Forest University School of Medicine in Google Maps
CompletedOne Study Center