Randomized Trial of Homocysteine-Lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
30 Years
85 Years
Both
Acute Myocardial Infarction
Trial Information
Randomized Trial of Homocysteine-Lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
The primary end point was a composite of
Principal Investigator
Kaare H Bonaa, M.D., Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Community Medicine, University of Tromsø, Norway
Authority:
Norway: Norwegian Medicines Agency
Study ID:
NRC 112812/320
NCT ID:
NCT00266487
Start Date:
December 1998
Completion Date:
March 2004
Related Keywords:
- Acute Myocardial Infarction
- Homocysteine
- B vitamins
- Folic acid
- Randomized trial
- Secondary prevention
- Cardiovascular Diseases
- Infarction
- Myocardial Infarction
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