The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct - 12/12/18

Doi : 10.1016/j.ahj.2018.07.012

Philip Joseph, MD ^a, Prem Pais, MD ^b, Antonio L Dans, MD ^c, Jackie Bosch, PhD ^a,^d, Denis Xavier, MD, MSc ^b, Patricio Lopez-Jaramillo, MD, PhD ^e, Khalid Yusoff, MBBS ^f, Anwar Santoso, MD, PhD ^g, Shamim Talukder, MBBS, MPhil ^h, Habib Gamra, MD ⁱ, Karen Yeates, MD ^j, Paul Camacho Lopez, MD ^e, Jessica Tyrwhitt, BSc ^a, Peggy Gao, MSc ^a, Koon Teo, MD ^a, Salim Yusuf, MBBS, DPhil ^a,^{^⁎}
on behalf of the TIPS-3 Investigators
^a Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada
^b St. John's Medical College, Bangalore, India
^c College of Medicine, University of the Philippines, Manila, Philippines
^d School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
^e Research Institute and Clinic of Metabolic Syndrome and Diabetes, Fundacion Oftalmologica de Santander FOSCAL, Universidad de Santander UDES, Bucaramanga, Colombia
^f UiTM Selayang, Selangor and UCSI University, Cheras, Kuala Lumpur, Malaysia
^g Universitas Indonesia and Department of Cardiology - Vascular Medicine, National Cardiovascular Centre, Harapan Kita Hospital, Jakarta, Indonesia
^h Eminence, Dhaka, Bangladesh
ⁱ Fattouma Bourguiba University Hospital and University of Monastir, Tunisia
^j Department of Medicine, Queen's University, Kingston, Ontario, Canada

^⁎Reprint requests: Salim Yusuf M.B.B.S, D.Phil, MRCP, Population Health Research Institute, DCBVSRI, Hamilton General Hospital, 237 Barton Street East, Hamilton, ON, Canada, L8L 2X2.Population Health Research Institute, DCBVSRI, Hamilton General Hospital237 Barton Street EastHamiltonONL8L 2X2Canada

Abstract

Background

It 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.

Methods

TIPS-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.

Results

The 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.

Conclusion

Results of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.

Le texte complet de cet article est disponible en PDF.

Plan

Introduction and rationale of the TIPS-3

Methods

Study objectives, design, and interventions

Study population and eligibility

Primary, secondary, and additional pre-specified outcomes

Sample size and data analysis

Baseline characteristics

Regulatory factors, study initiation and study enrollment

Time required to achieve regulatory approval in each country

Regulatory changes in India and enrollment trends in TIPS-3

Discussion

Conclusions

Conflicts of Interest and Disclosures

Funding of Study

Author Contributions

	RCT# NCT01646437.
	Registration: ClinicalTirals.gov (NCT01646437).

Export

Vol 206

P. 72-79 - décembre 2018 Retour au numéro

Article précédent

Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV)
Christopher P. Cannon, Darren K. McGuire, Richard Pratley, Sam Dagogo-Jack, James Mancuso, Susan Huyck, Bernard Charbonnel, Weichung J. Shih, Silvina Gallo, Urszula Masiukiewicz, Gregory Golm, Francesco Cosentino, Brett Lauring, Steven G. Terra, VERTIS-CV Investigators

| Article suivant

Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study
Aruna D. Pradhan, Nina P. Paynter, Brendan M. Everett, Robert J. Glynn, Pierre Amarenco, Marshall Elam, Henry Ginsberg, William R. Hiatt, Shun Ishibashi, Wolfgang Koenig, Børge G. Nordestgaard, Jean-Charles Fruchart, Peter Libby, Paul M Ridker

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

connectez-vous ou créez un compte

The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct - 12/12/18

Abstract

Background

Methods

Results

Conclusion

Plan

Export citations

Fichier

Contenu

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL