The Norwegian Vitamin Trial (NORVIT)

Acute Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266487
• Other study ID #: NRC 112812/320
• Secondary ID: NRC 138859/320
• Status: Completed
• Phase: N/A
• First received: December 15, 2005
• Last updated: May 3, 2017
• Start date: December 1998
• Est. completion date: March 2004

Study information

• Verified date: May 2017
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3750
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Folic acid

• Vitamin B12

• Vitamin B6

Locations

Country	Name	City	State
Norway	Institute of Community Medicine, University of Tromsø	Tromsø

Sponsors (7)

Lead Sponsor	Collaborator
University of Tromso	Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway, The Council on Health and Rehabilitation, Norway, The International Federation of Red Cross and Red Crescent Societies, The Norwegian Council on Cardiovascular Disease, The Research Council of Norway, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bønaa KH, Njølstad 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was a composite of
Primary	nonfatal myocardial infarction,
Primary	fatal myocardial infarction,
Primary	nonfatal stroke,
Primary	fatal stroke, and
Primary	sudden death attributed to coronary heart disease.
Secondary	Individual components of the primary end point, i.e.
Secondary	Nonfatal myocardial infarction
Secondary	Fatal myocardial infarction
Secondary	Nonfatal stroke
Secondary	Fatal stroke
Secondary	In addition the following secondary outcomes:
Secondary	Unstable angina pectoris requiring hospitalization
Secondary	Percutaneous coronary revascularization
Secondary	Coronary-artery bypass grafting
Secondary	Death from any cause
Secondary	Cancer
Secondary	Pulmonary embolus
Secondary	Transitoric ischemic attack
Secondary	Surgery for abdominal aortic aneurysm
Secondary	Plasma homocysteine levels
Secondary	Plasma levels of B vitamins