The International Polycap Study 3 (TIPS-3)
Summary
The randomized 2x2x2 factorial design placebo controlled trial will enroll 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. Eligible and consenting individuals will be randomized to receive either the active study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The study will include people from at 10 countries, will be conducted by an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at Hamilton Health Sciences.
Timeline
- Start
- 2012-06
- Primary completion
- 2020-06-30
- Completion
- 2021-08-30
Outcome
Mixed primary results
paper primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) PMID 33186492 ↗
paper hazard ratio, 0.69; 95% CI, 0.50 to 0.97). PMID 33186492 ↗
paper hazard ratio, 0.86; 95% CI, 0.67 to 1.10. PMID 33186492 ↗
Publications
- Joseph P, Pais P, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder SH, Christou C, Dagenais G, Tyrwhitt J, Bosch J, Dans A, Yusuf S; International Polycap Study (TIPS)-3 Investigators. Vitamin D supplementation and adverse skeletal and non-skeletal outcomes in individuals at increased cardiovascular risk: Results from the International Polycap Study (TIPS)-3 randomized controlled trial. Nutr Metab Cardiovasc Dis. 2023 Feb;33(2):434-440. doi: 10.1016/j.numecd.2022.11.001. Epub 2022 Nov 15.
- Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.
- Joseph P, Pais P, Dans AL, Bosch J, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Talukder S, Gamra H, Yeates K, Lopez PC, Tyrwhitt J, Gao P, Teo K, Yusuf S; TIPS-3 Investigators. The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct. Am Heart J. 2018 Dec;206:72-79. doi: 10.1016/j.ahj.2018.07.012. Epub 2018 Aug 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 75 mg | — |
| Subject | Atenolol | Other / unclassified | 100 mg | — |
| Subject | Hydrochlorothiazide | Unknown | 25 mg | — |
| Subject | Ramipril | Small molecule | 10 mg | — |
| Subject | Simvastatin | Small molecule | 40 mg | — |
| Subject | Vitamin D | Other / unclassified | 60000 iu | Oral |