The Norwegian Vitamin Trial (NORVIT)
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease
Acute Myocardial Infarction
Drug: Folic acid
Drug: Vitamin B12
Drug: Vitamin B6
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Homocysteine-Lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT)|
- 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.
- Individual components of the primary end point, i.e.
- Nonfatal myocardial infarction
- Fatal myocardial infarction
- Nonfatal stroke
- Fatal stroke
- In addition the following secondary outcomes:
- Unstable angina pectoris requiring hospitalization
- Percutaneous coronary revascularization
- Coronary-artery bypass grafting
- Death from any cause
- Pulmonary embolus
- Transitoric ischemic attack
- Surgery for abdominal aortic aneurysm
- Plasma homocysteine levels
- Plasma levels of B vitamins
|Study Start Date:||December 1998|
|Estimated Study Completion Date:||March 2004|
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.
|Institute of Community Medicine, University of Tromsø|
|Tromsø, Norway, N-9037|
|Principal Investigator:||Kaare H Bonaa, M.D., Ph.D||Institute of Community Medicine, University of Tromsø, Norway|