Trial name or title |
The International Polycap Study‐3 |
Methods |
2 x 2 x 2 randomised controlled trial, factorial design (3 arms: Polycap, aspirin, vitamin D) |
Participants |
5000 participants (women 60 years or older and men 55 years or older) without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications and INTERHEART risk score of 10 or greater |
Interventions |
Polycap vs. placebo; embedded in trial comparing enteric coated aspirin vs. placebo and vitamin D vs. placebo |
Outcomes |
Composite of major CVD (CV death, non‐fatal stroke, non‐fatal MI), plus heart failure, resuscitated cardiac arrest, or revascularisation with evidence of ischaemia in participants taking Polycap versus placebo |
Starting date |
June 2012; protocol updated on clinicaltrials.gov on May 2015 (ClinicalTrials.gov Identifier: NCT01646437) |
Contact information |
Dr. Salim Yusuf, Population Health Research Institute |
Notes |
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