The Norwegian Vitamin Trial (NORVIT)

Study Overview
=================
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.

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)

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Folic acid
* Drug: Vitamin B12
* Drug: Vitamin B6


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folic acid|nan|
|Drug: Vitamin B12|nan|
|Drug: Vitamin B6|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Cancer |  |  | 
| Pulmonary embolus |  |  | 
| Transitoric ischemic attack |  |  | 
| Surgery for abdominal aortic aneurysm |  |  | 
| Plasma homocysteine levels |  |  | 
| Plasma levels of B vitamins |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Homocysteine, B vitamins, Folic acid, Randomized trial, Secondary prevention