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.

Conditions

• Cardiovascular Disease
• Fractures
• Cancers

Interventions

DRUG

Polycap

Polycap (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) taken once daily

DRUG

Aspirin

75 mg daily

DRUG

Vitamin D

60,000 IU monthly

DRUG

Matching Placebo

Matching Placebo

Sponsors & Collaborators

• Cadila Pharnmaceuticals

  collaborator INDUSTRY

• Wellcome Trust

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Heart and Stroke Foundation of Ontario

  collaborator OTHER

• Population Health Research Institute

  lead OTHER

Principal Investigators

• Salim Yusuf · Population Health Research Institute

• Prem Pais · St. John's Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2020-06-30

Completion

2021-08-30

Countries

• Bangladesh
• Canada
• Colombia
• India
• Indonesia
• Malaysia
• Philippines
• Tanzania
• Tunisia

Study Locations