HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
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|ClinicalTrials.gov Identifier: NCT00106886|
Recruitment Status : Unknown
Verified March 2005 by McMaster University.
Recruitment status was: Active, not recruiting
First Posted : April 1, 2005
Last Update Posted : September 20, 2005
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Myocardial Infarction Stroke Cancer||Drug: Folic acid, vitamin B6 and B12 or placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||October 2005|
- The composite of cardiovascular death, myocardial infarction (MI) and stroke
- Total major ischemic events (includes CV [cardiovascular] death, MI, stroke, hospitalizations for UA [unstable angina] and revascularizations)
- Hospitalization for unstable angina
- Hospitalization for congestive heart failure (CHF)
- Hospitalization for revascularization procedures
- Total mortality
- Other hospitalizations
- Diabetic complications (laser therapy, dialysis, nephropathy or new diagnosis of diabetes)
- The composite of death due to cancer, hospitalization for cancer and new diagnosis of cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106886
|McMaster University and Hamilton Health Sciences Corporation|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Eva M Lonn, MD MSc FRCPC FACC||McMaster University|