Acute Myocardial Infarction
Conditions
Keywords
Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention
Brief summary
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease
Detailed description
Observational studies have demonstrated that elevated levels of plasma total homocysteine is a risk factor for cardiovascular disease. The purpose of this trial is to evaluate the efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in patients who have experienced an acute myocardial infarction. This controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization. Participants will be randomized, in a two-by-two factorial design, to receive one of the following four treatments: A, folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg per day; C, vitamin B6 40 mg per day; D, placebo. The primary end point during 3.5 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease.
Interventions
Sponsors
The Research Council of Norway
The Council on Health and Rehabilitation, Norway
The Norwegian Council on Cardiovascular Disease
The Royal Norwegian Ministry of Health
The International Federation of Red Cross and Red Crescent Societies
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
University of Tromso
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction within 7 days prior to randomization * Men and women aged 30-85 years * Written informed consent
Exclusion criteria
* Coexisting disease that shortens expected survival to less than 4 years * Ongoing treatment with B vitamins * Expected poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point was a composite of | — |
| nonfatal myocardial infarction, | — |
| fatal myocardial infarction, | — |
| nonfatal stroke, | — |
| fatal stroke, and | — |
| sudden death attributed to coronary heart disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unstable angina pectoris requiring hospitalization | — |
| Percutaneous coronary revascularization | — |
| Coronary-artery bypass grafting | — |
| Death from any cause | — |
| Cancer | — |
| Individual components of the primary end point, i.e. | — |
| Transitoric ischemic attack | — |
| Surgery for abdominal aortic aneurysm | — |
| Plasma homocysteine levels | — |
| Plasma levels of B vitamins | — |
| Pulmonary embolus | — |
| Nonfatal myocardial infarction | — |
| Fatal myocardial infarction | — |
| Nonfatal stroke | — |
| Fatal stroke | — |
| In addition the following secondary outcomes: | — |
Countries
Norway
Outcome results
None listed