HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Cardiovascular disease (CVD) remains a major cause of mortality and morbidity in most
developed countries and accounts for approximately 40% of all deaths in Canada. Reductions
in cholesterol, lowering of blood pressure and smoking cessation have been shown to be
effective strategies in cardiovascular prevention; however, these major "classical
cardiovascular risk factors" along with nonmodifiable risk factors, cannot fully explain why
certain individuals develop atherosclerotic cardiovascular diseases, while others do not.
Other "emerging" cardiovascular risk factors are currently under investigation. There is a
large body of consistent, biologically plausible evidence linking hyperhomocyst(e)inemia to
cardiovascular risk and the association is graded. A simple, nontoxic therapeutic
intervention in the form of multivitamins - folic acid and vitamins B6 and B12 - has been
shown to be highly effective in reducing homocyst(e)ine levels, irrespective of the
underlying cause. To date, however, there are no good clinical trials evaluating the
efficacy of homocyst(e)ine-lowering therapies in reducing major cardiovascular events. The
impact of this simple intervention on cardiovascular morbidity and mortality remains to be
demonstrated.
Study Hypothesis: Evaluate if long-term therapy with folic acid and vitamins B6 and B12
compared to placebo reduces the risk of major fatal and nonfatal cardiovascular events.
Importance of the Study: The "homocyst(e)ine theory of atherosclerosis" remains an important
unanswered question in cardiovascular medicine. If indeed a combination of multivitamins is
found to be effective in reducing cardiovascular events, it is expected that this safe,
inexpensive and easily administered therapy would be widely used world-wide. Therefore, the
results of this trial could have a significant public health impact.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
The composite of cardiovascular death, myocardial infarction (MI) and stroke
Eva M Lonn, MD MSc FRCPC FACC
Principal Investigator
McMaster University
Canada: Health Canada
HOPE-2, CIHR FRN # MT-15428
NCT00106886
December 1999
October 2005
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