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;
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The primary end point was a composite of
Kaare H Bonaa, M.D., Ph.D
Institute of Community Medicine, University of Tromsø, Norway
Norway: Norwegian Medicines Agency