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. 2012 Oct 17;2012(10):CD008176. doi: 10.1002/14651858.CD008176.pub2

HOPE 2000.

Methods

  • Study design: parallel RCT

  • Time frame: NS
Participants Inclusion criteria

  • Setting: international (19 countries)

  • Countries: North and South America, Europe

  • The original trial (HOPE) enrolled people with and without diabetes at high‐risk for cardiovascular events

  • Number: treatment group (499); control group (494)

  • Mean age ± SD: treatment group (68.6 ± 6.8); control group (68.3 ± 7.0)

  • Females: treatment group (11.6%); control group (13.8%)


Exclusion criteria: NS
Interventions

  • Treatment group

    • Vitamin E (RRR‐ɑ‐tocopheryl acetate) 400 IU

  • Control group

    • Matching placebo
Outcomes

  • Composite of myocardial infarction, stroke, or death from cardiovascular disease

  • Cardiovascular mortality

  • All‐cause mortality

  • Cardiovascular disease

  • Coronary heart disease

  • Cerebrovascular disease
Notes Post‐hoc analysis of an international, multicentre RCT‐ Heart Outcomes Prevention Evaluation (HOPE) Study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomisation using a 4 digit code, performed in blocks of 8 and stratified per centre
Allocation concealment (selection bias) Low risk Study protocol has been published and has reported the use of central randomisation
Blinding (performance bias and detection bias) 
 All outcomes Low risk Study has reported the use of double blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Compliance reported, all analyses have been reported to be conducted based on the intention‐to‐treat principle
Selective reporting (reporting bias) Unclear risk Study protocol has been published and has specified study design. All pre‐specified outcomes have been published
Other bias High risk Funding: This study was funded by the Medical Research Council of Canada (Grants MT12790 and UI12362); Hoechst‐Marion Roussel; AstraZeneca; King Pharmaceuticals; Natural Source Vitamin E Association; NEGMA and the Heart and Stroke Foundation of Ontario. Salim Yusuf was supported by a Senior Scientist award of the Medical Research Council of Canada, and a Heart and Stroke Foundation of Ontario research chair.