NCT00106886

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 homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 20, 2005

Status Verified

March 1, 2005

First QC Date

March 31, 2005

Last Update Submit

September 16, 2005

Conditions

Cardiovascular DiseaseMyocardial InfarctionStrokeCancer

Keywords

homocysteinefolic acidmicronutrientsmultivitaminsvitamin supplements

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

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

  • Hospitalization for unstable angina

  • Hospitalization for congestive heart failure (CHF)

  • Hospitalization for revascularization procedures

  • Total mortality

  • +3 more secondary outcomes

Interventions

Folic acid, vitamin B6 and B12 or placeboDRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • i) 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University and Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (6)

  • 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.

    PMID: 19228852DERIVED

  • 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.

    PMID: 18940900DERIVED

  • 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.

    PMID: 18003666DERIVED

  • 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.

    PMID: 17954810DERIVED

  • 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.

    PMID: 17470822DERIVED

  • 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.

    PMID: 16531613DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionStrokeNeoplasms

Interventions

Folic AcidVitamin B 6Vitamin B 12

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPicolinesPyridinesHeterocyclic Compounds, 1-RingCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Eva M Lonn, MD MSc FRCPC FACC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2005

First Posted

April 1, 2005

Study Start

December 1, 1999

Study Completion

October 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-03

Locations

CA(1)