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Cardiovascular DiseasePhase 4NCT00106886

HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)

A Phase 4 study of Cardiovascular Disease and Myocardial Infarction, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus. Read more about this study

Who is it for?
Ages 55 years and older
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,000 participants
Where
1 siteCanada
Study dates
Dec 1999to Oct 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women and men 55 years of age or over with established CVD and at high risk for future fatal and nonfatal CV events, defined as:
  • Documented coronary artery disease (CAD);
  • Documented peripheral vascular disease (PVD);
  • Documented cerebrovascular disease;
  • Diabetes with one of the following; additional cardiovascular risk factors:
  • hypertension (BP >160 mmHg systolic or >90 mmHg diastolic or on treatment); ii) total cholesterol >5.2 mmol/L (>200 mg/dl); iii) HDL cholesterol <0.9 mmol/L (3.5 mg/dl); iv) current cigarette smoker; v) any evidence of previous vascular disease
  • Provision of informed consent

Who cannot join

  • Current use of any vitamin supplements containing folic acid >200 micrograms/day. The patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree, they can be randomized to the study following a one month wash-out period.
  • Known previous adverse reactions to folic acid and/or vitamin B6 and/or B12.
  • Planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularization within the next 6 months.
  • Hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
  • Constrictive pericarditis.
  • Complex congenital heart disease.
Show all 11Show fewer
  • Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria.
  • Uncontrolled hypertension.
  • Cor pulmonale.
  • Heart transplant recipient.
  • Other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient's ability to complete the study, such as: *history of alcohol or drug abuse, *psychiatric disorders, *senility, *severe physical disability, *illnesses including terminal stage of cancer and other major systemic illnesses expected to limit the patient's ability to comply with the study protocol and to complete the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University and Hamilton Health Sciences Corporation

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.

Read the 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 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.

Being tested
Folic acid, vitamin B6 and B12 or placebo
Keywords
homocysteine, folic acid, micronutrients, multivitamins, vitamin supplements
Medical subject headings
Cardiovascular Diseases, Myocardial Infarction, Stroke, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Folic acid, vitamin B6 and B12 or placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The composite of cardiovascular death, myocardial infarction (MI) and stroke

Secondary outcomes (8)

  1. Total major ischemic events (includes CV [cardiovascular] death, MI, stroke, hospitalizations for UA [unstable angina] and revascularizations)

  2. Hospitalization for unstable angina

  3. Hospitalization for congestive heart failure (CHF)

  4. Hospitalization for revascularization procedures

  5. Total mortality

  6. Other hospitalizations

  7. Diabetic complications (laser therapy, dialysis, nephropathy or new diagnosis of diabetes)

  8. The composite of death due to cancer, hospitalization for cancer and new diagnosis of cancer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2005 (estimated)
  2. Study startDec 1999
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106886
Sponsor's protocol ID
HOPE-2, CIHR FRN # MT-15428
Status last verified
Mar 2005
First submitted
31 Mar 2005
Last updated
20 Sep 2005
Results posted
No

Publications

  • Saposnik G, Ray JG, Sheridan P, McQueen M, Lonn E; Heart Outcomes Prevention Evaluation 2 Investigators. Homocysteine-lowering therapy and stroke risk, severity, and disability: additional findings from the HOPE 2 trial. Stroke. 2009 Apr;40(4):1365-72. doi: 10.1161/STROKEAHA.108.529503. Epub 2009 Feb 19.

    PubMed 19228852

  • Held C, Sumner G, Sheridan P, McQueen M, Smith S, Dagenais G, Yusuf S, Lonn E. Correlations between plasma homocysteine and folate concentrations and carotid atherosclerosis in high-risk individuals: baseline data from the Homocysteine and Atherosclerosis Reduction Trial (HART). Vasc Med. 2008 Nov;13(4):245-53. doi: 10.1177/1358863X08092102.

    PubMed 18940900

  • Mann JF, Sheridan P, McQueen MJ, Held C, Arnold JM, Fodor G, Yusuf S, Lonn EM; HOPE-2 investigators. Homocysteine lowering with folic acid and B vitamins in people with chronic kidney disease--results of the renal Hope-2 study. Nephrol Dial Transplant. 2008 Feb;23(2):645-53. doi: 10.1093/ndt/gfm485. Epub 2007 Nov 14.

    PubMed 18003666

  • Sawka AM, Ray JG, Yi Q, Josse RG, Lonn E. Randomized clinical trial of homocysteine level lowering therapy and fractures. Arch Intern Med. 2007 Oct 22;167(19):2136-9. doi: 10.1001/archinte.167.19.2136. No abstract available.

    PubMed 17954810

  • Ray JG, Kearon C, Yi Q, Sheridan P, Lonn E; Heart Outcomes Prevention Evaluation 2 (HOPE-2) Investigators. Homocysteine-lowering therapy and risk for venous thromboembolism: a randomized trial. Ann Intern Med. 2007 Jun 5;146(11):761-7. doi: 10.7326/0003-4819-146-11-200706050-00157. Epub 2007 Apr 30.

    PubMed 17470822

  • Lonn E, Yusuf S, Arnold MJ, Sheridan P, Pogue J, Micks M, McQueen MJ, Probstfield J, Fodor G, Held C, Genest J Jr; Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med. 2006 Apr 13;354(15):1567-77. doi: 10.1056/NEJMoa060900. Epub 2006 Mar 12.

    PubMed 16531613

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Cardiovascular Disease and Myocardial Infarction, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite of cardiovascular death, myocardial infarction (MI) and stroke. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106886, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.

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