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. 2017 Mar 6;2017(3):CD009868. doi: 10.1002/14651858.CD009868.pub3

NCT01646437.

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