Heart Outcomes Prevention Evaluation-2 (HOPE-2) study
| ISRCTN | ISRCTN14017017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14017017 |
| ClinicalTrials.gov (NCT) | NCT00106886 |
| Protocol serial number | MCT-15428 |
| Sponsor | McMaster University (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15428) |
- Submission date
- 05/09/2005
- Registration date
- 05/09/2005
- Last edited
- 03/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eva Lonn
Scientific
Scientific
HGH-McMaster Clinic
237 Barton Street East
Room 254
Hamilton
L8L 2X2
Canada
| Phone | +1 905 526 0970 |
|---|---|
| lonnem@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HOPE-2 |
| Study objectives | 1. To evaluate whether prolonged therapy with folic acid and vitamins B6 and B12 compared to placebo reduces the risk of cardiovascular death, myocardial infarction (MI) and stroke (major fatal and non-fatal cardiovascular [CV] events) 2. To evaluate the effects of the study intervention on major fatal and non-fatal CV and revascularisation procedures and on total important ischaemic events |
| Ethics approval(s) | Hamilton Health Sciences Corporation and McMaster University approved on the 17th November 1999. |
| Health condition(s) or problem(s) studied | Cardiovascular disease, myocardial infarction (MI), stroke, cancer |
| Intervention | Combination pill containing: Folic acid 2.5 mg, vitamin B6 50 mg, vitamin B12 1 mg, or placebo |
| Intervention type | Supplement |
| Primary outcome measure(s) |
The composite of cardiovascular death, myocardial infarction (MI) and stroke. |
| Key secondary outcome measure(s) |
1. Total major ischaemic events, including CV death, MI, stroke, hospitalisations for unstable angina and revascularisations |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 5552 |
| Key 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 |
| Key exclusion criteria | 1. Current use of any vitamin supplements containing folic acid greater than 200 µg/day. Patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree they can be randomised 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 revascularisation within the next 6 months 4. Haemodynamically 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 patients 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 patients ability to comply with the study protocol and to complete the study |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
HGH-McMaster Clinic
Hamilton
L8L 2X2
Canada
L8L 2X2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/04/2006 | Yes | No | |
| Results article | results | 05/06/2007 | Yes | No | |
| Results article | results | 01/04/2009 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
