ArticleAmerican heart journal2018
The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct.
Article in American heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Role of calcium &/or vitamin D supplementation in preventing osteoporotic fracture in the elderly: A systematic review & meta-analysis.The Indian journal of medical research · 2023Pooled it
- Pooled it
- Vitamin D and Calcium for the Prevention of Fracture: A Systematic Review and Meta-analysis.JAMA network open · 2019Pooled it
- Polypill with or without Aspirin in Persons without Cardiovascular Disease.The New England journal of medicine · 2021 · on this mapTrial
- South Asian Cardiovascular Risk: Role of Coronary Artery Calcium Scoring and Computed Tomography Angiography.JACC. Asia · 2026Review
- A Bayesian Multi-Factorial Design and Analysis for Estimating Combined Effects of Multiple Interventions in a Pragmatic Clinical Trial to Improve Dementia Care.Statistics in medicine · 2025Article
- The Future of Chronic Kidney Disease Treatment: Combination Therapy (Polypill) or Biomarker-Guided Personalized Intervention?Biomolecules · 2025Review
- Reducing premature mortality from cardiovascular diseases in low and middle income countries: The role of Polypill in public health policy.International journal of cardiology. Cardiovascular risk and prevention · 2025Review
- Expert consensus on vitamin D in osteoporosis.Annals of joint · 2025Review
- Cost effectiveness analysis of a fixed dose combination pill for primary prevention of cardiovascular disease from an individual participant data meta-analysis.EClinicalMedicine · 2024Article
- Low Vitamin D Status Is Associated with Increased Risk of Mortality in Korean Men and Adults with Hypertension: A Population-Based Cohort Study.Nutrients · 2022Article
- Is There Proof of Extraskeletal Benefits From Vitamin D Supplementation From Recent Mega Trials of Vitamin D?JBMR plus · 2021Article
- Aspirin for Primary Prevention in Adults Older than 70 Years is Not Supported by High-Quality Trial Data and May Cause Harm.The American journal of medicine · 2020Article
- Consensus statement from 2Reviews in endocrine & metabolic disorders · 2020Article
- Challenges in management and prevention of ischemic heart disease in low socioeconomic status people in LLMICs.BMC medicine · 2019Article
- Cardiovascular Diseases in India Compared With the United States.Journal of the American College of Cardiology · 2018Review
- [Management of different cardiovascular risk factors with a combination tablet (polypill)].Herz · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 9 institutions in 7 countries.
Funding
Abstract
backgroundIt is hypothesized that in individuals without clinical cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction in CVD risk could be achieved using fixed dose combination (FDC) therapy (usually comprised of multiple blood-pressure agents and a statin [with or without aspirin]) in a single "polypill". However, the impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial.
methodsTIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events.
resultsThe study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk.
conclusionResults of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.