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Heart Outcomes Prevention Evaluation-2 (HOPE-2) study
ISRCTN ISRCTN14017017
DOI 10.1186/ISRCTN14017017
ClinicalTrials.gov identifier NCT00106886
EudraCT number
Public title Heart Outcomes Prevention Evaluation-2 (HOPE-2) study
Scientific title
Acronym HOPE-2
Serial number at source MCT-15428
Study hypothesis 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
Lay summary
Ethics approval Hamilton Health Sciences Corporation and McMaster University approved 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 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 patientís 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 patientís 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 ischaemic events, including CV death, MI, stroke, hospitalisations for unstable angina and revascularisations
2. Total mortality
3. Hospitalisation for unstable angina (UA)
4. Hospitalisation for congestive heart failure (CHF)
5. Revascularisation procedures
6. Incident cancer
7. Cancer death
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15428)
Trial website http://www.phri.ca
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16531613
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17470822
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19228852
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
  Email 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 03/08/2009
Date ISRCTN assigned 05/09/2005
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