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21 November 2008
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| [ Print-friendly version ] |
| Heart Outcomes Prevention Evaluation-2 (HOPE-2) study |
| ISRCTN | ISRCTN14017017 |
| ClinicalTrials.gov identifier | NCT00106886 |
| Public title | Heart Outcomes Prevention Evaluation-2 (HOPE-2) study |
| Scientific title | |
| Acronym | HOPE-2 |
| Serial number at source | MCT-15428 |
| Study hypothesis |
To evaluate whether prolonged therapy with folic acid and vitamins B6 and B12 compared to placebo reduces the risk of cardiovascular death, MI and stroke (major fatal and nonfatal cardiovascular [CV] events).
Will also evaluate the effects of the study intervention on major fatal and nonfatal CV and revascularization procedures and on total important ischemic events. |
| Ethics approval | Received from Hamilton Health Sciences Corporation and McMaster University on the 17th November 1999. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Cardiovascular disease, myocardial infarction (MI), stroke, cancer |
| Participants - inclusion criteria |
1. 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:
1.1. Documented Coronary Artery Disease (CAD) 1.2. Documented Peripheral Vascular Disease (PVD) 1.3. Documented cerebrovascular disease 1.4. Diabetes with one of the following additional cardiovascular risk factors: 1.4.1. Hypertension (Blood Pressure [BP] greater than 160 mmHg systolic or greater than 90 mmHg diastolic or on treatment) 1.4.2. Total cholesterol greater than 5.2 mmol/l (greater than 200 mg/dl) 1.4.3. High Density Lipoprotein (HDL) cholesterol less than 0.9 mmol/l (3.5 mg/dl) 1.4.4. Current cigarette smoker 1.4.5. Any evidence of previous vascular disease 2. Provision of informed consent |
| Participants - exclusion criteria |
1. Current use of any vitamin supplements containing folic acid >200 µg/day. 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.
2. Known previous adverse reactions to folic acid, vitamin B6 or B12 3. 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 4. Hemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve) 5. Constrictive pericarditis 6. Complex congenital heart disease 7. Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria) 8. Uncontrolled hypertension 9. Cor pulmonale 10. Heart transplant recipient 11. 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 cancer and other major systemic illnesses expected to limit the patient’s ability to comply with the study protocol and to complete the study |
| Anticipated start date | 01/04/1999 |
| Anticipated end date | 31/03/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 5552 |
| Interventions | Combination pill containing: Folic acid 2.5 mg, vitamin B6 50 mg, vitamin B12 1 mg, or placebo |
| Primary outcome measure(s) | The composite of cardiovascular death, myocardial infarction (MI) and stroke. |
| Secondary outcome measure(s) |
1. Total major ischemic events, including CV death, MI, stroke, hospitalizations for unstable angina and revascularizations
2. Total mortality 3. Hospitalization for unstable angina (UA) 4. Hospitalization for congestive heart failure (CHF) 5. Revascularization procedures 6. Incident cancer 7. Cancer Death |
| Sources of funding | Canadian Institutes of Health Research (CIHR) - http://www.cihr-irsc.gc.ca (ref: MCT-15428) |
| Trial website | http://www.phri.ca |
| Publications |
Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16531613 2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17470822 |
| Contact name | Dr Eva Lonn |
| Address |
HGH-McMaster Clinic
237 Barton Street East Room 254 |
| City/town | Hamilton |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Tel | +1 905 526 0970 |
| Fax | +1 905 527 5380 |
| lonnem@mcmaster.ca | |
| Sponsor | McMaster University (Canada) |
| Address |
Office of the Associate Dean
Research McMaster University Faculty of Health Sciences 1200 Main Street West Room HSC-3N8 |
| City/town | Hamilton |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 05/09/2005 |
| Last edited | 28/08/2007 |
| Date ISRCTN assigned | 05/09/2005 |
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