Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106886
Status:
UNKNOWN
Last Update Posted:
2005-09-20
First Post:
2005-03-31
Brief Title:
HOPE-2 Study Heart Outcomes Prevention Evaluation-2 Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
HOPE-2 Study Heart Outcomes Prevention Evaluation-2 Study
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid vitamins B6 and B12 aimed at homocysteine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease andor diabetes mellitus
Detailed Description:
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 hyperhomocysteinemia 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 homocysteine levels irrespective of the underlying cause To date however there are no good clinical trials evaluating the efficacy of homocysteine-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 homocysteine 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 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 homocysteine 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None