Clinical trial NCT00266487: The Norwegian Vitamin Trial (NORVIT)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Homocysteine
B vitamins
Folic acid
Randomized trial
Secondary prevention
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: The Council on Health and Rehabilitation, Norway
name: The Norwegian Council on Cardiovascular Disease
name: The Royal Norwegian Ministry of Health
name: The International Federation of Red Cross and Red Crescent Societies
name: Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
First posted: 2005-12-16
Enrollment: 3750
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary end point was a composite of
measure: nonfatal myocardial infarction,
measure: fatal myocardial infarction,
measure: nonfatal stroke,
measure: fatal stroke, and
measure: sudden death attributed to coronary heart disease.
Secondary outcomes:
measure: Individual components of the primary end point, i.e.
measure: Nonfatal myocardial infarction
measure: Fatal myocardial infarction
measure: Nonfatal stroke
measure: Fatal stroke
measure: In addition the following secondary outcomes:
measure: Unstable angina pectoris requiring hospitalization
measure: Percutaneous coronary revascularization
measure: Coronary-artery bypass grafting
measure: Death from any cause
measure: Cancer
measure: Pulmonary embolus
measure: Transitoric ischemic attack
measure: Surgery for abdominal aortic aneurysm
measure: Plasma homocysteine levels
measure: Plasma levels of B vitamins
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Institute of Community Medicine, University of Tromsø
Study officials:
affiliation: Institute of Community Medicine, University of Tromsø, Norway
name: Kaare H Bonaa, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonaa KH, Njolstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, Wang H, Nordrehaug JE, Arnesen E, Rasmussen K; NORVIT Trial Investigators. Homocysteine lowering and cardiovascular events after acute myocardial infarction. N Engl J Med. 2006 Apr 13;354(15):1578-88. doi: 10.1056/NEJMoa055227. Epub 2006 Mar 12.
citation: Dhar I, Lysne V, Svingen GFT, Ueland PM, Gregory JF, Bonaa KH, Nygard OK. Elevated plasma cystathionine is associated with increased risk of mortality among patients with suspected or established coronary heart disease. Am J Clin Nutr. 2019 Jun 1;109(6):1546-1554. doi: 10.1093/ajcn/nqy391.