NORVIT

The NORVIT study is initiated, designed and coordinated by the cardiovascular research group at ISM. Since December 1998, NORVIT has recruited 3,750 patients with acute myocardial infarction from 35 Norwegian hospitals, and 90% of participants report adherence to the study medication protocol.



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Large clinical trial
NORVIT is so far the largest randomised clinical trial funded by the Research Council of Norway, and will probably be the first to report on the effect of homocysteine lowering on hard clinical endpoints. The follow-up will be completed during the spring of 2004, when we estimate to reach the predefined 750 primary endpoints. A sub-project will test the hypothesis that vitamin B therapy protects against loss of cognitive function.

Evaluation positive
In 2000, NORVIT was audited by Smerud Medical Research AS on behalf of the Research Council of Norway. The evaluation was based on the international criteria of GCP (Good Clinical Practice) that pharmaceutical industry studies should adhere to. “Executive summary of audit” states: “We conclude on an overall basis that the NORVIT study is being managed, both centrally and locally, in accordance with good scientific principles…”

Hypothesis
Plasma homocysteine levels can be lowered easily, inexpensively and without known side effects by vitamin B-therapy. NORVIT is a double blind, randomised, placebo controlled secondary prevention trial, testing the hypotheses that long-term (3 year) treatment with a folate/B12 -combination or vitamin B6 (2x2 factorial design) may reduce morbidity and mortality in myocardial infarction survivors. The primary endpoint is a composite of fatal and non-fatal myocardial infarction and stroke.