The International Polycap Study 3 (TIPS-3)
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Purpose
The randomized 2x2x2 factorial design placebo controlled trial will enroll at least 5500 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 least 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Fractures Cancers |
Drug: Polycap DS Drug: enteric coated aspirin Drug: cholecalciferol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The International Polycap Study 3 (TIPS-3) is a Randomized Double-blind Placebo-controlled Trial for the Evaluation of a Polycap, Low Dose Aspirin and Vitamin D Supplementation in Primary Prevention |
- Composite of major CVD (CV death, non-fatal stroke, non-fatal MI), plus heart failure, resuscitated cardiac arrest, or revascularization with evidence of ischemia in participants taking Polycap versus placebo [ Time Frame: Particpants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
- Composite of CV events (CV death, MI or stroke) and cancer in participants taking aspirin versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
- Risk of fractures in participants taking vitamin D versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
- Composite of CV death, non-fatal stroke, and nonfatal MI in participants taking Polycap versus placebo [ Time Frame: Participants will be followed for an average of 5 years ] [ Designated as safety issue: No ]
- Composite outcome of CV events and cancers after 10 years of follow up in participants taking aspirin versus placebo [ Time Frame: Participants will be followed for 10 years ] [ Designated as safety issue: No ]
- Composite outcome of CV events, fractures and cancers, and the risk of the falls at 10 years of follow up in participants taking vitamin D versus placebo [ Time Frame: Participants will be followed for 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5500 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Polycap DS |
Drug: Polycap DS
Polycap DS (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) - daily
|
| Placebo Comparator: Aspirin |
Drug: enteric coated aspirin
75 mg daily
|
| Placebo Comparator: Vitamin D |
Drug: cholecalciferol
60,000 IU monthly
|
Detailed Description:
Cardiovascular disease (CVD), cancers and osteoporosis collectively make up the largest disease burden globally. CVD is the major cause of death and disability and affects about half of the population over their lifetimes. Cancers are a leading cause of death and it accounts for 13.0% of all deaths. The commonest forms include lung, breast, prostate, colorectum, stomach and liver cancer. It is estimated that over 200 hundred million people worldwide are living with osteoporosis. This is the underlying pathologic predisposition to fractures of the hip, vertebral body, and distal forearm. CVD, cancers and osteoporotic fractures increase with age and so their burden is expected to substantially increase over the next few decades. Simple, safe and effective preventive strategies which can reduce the incidence and prevalence of these 3 diseases are therefore urgently needed
It is suggested that this polypill could be given to all individuals with a CVD event as well as to anyone over 55 years (primary prevention) without the need for any measurement of risk factors. The polypill contains 3 blood pressure lowing medications and a statin in a single tablet. This includes hydrochlorothiazide (25 mg), atenolol (100 mg), ramipril (10 mg) and simvastatin (40 mg). In addition, to the polypill (Polycap), participants will be randomized to receive aspirin (75mg) and vitamin D (60,000 IU monthly). This factorial design on 3 distinct treatment arms which could reduce CVD, fractures and cancers could have large implications for the prevention of several of the important chronic diseases in middle and old age, using safe and inexpensive medications/supplements.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men aged ≥ 55 years and women aged ≥ 60 years with and INTERHEART risk score of 10 or greater
- Provision of informed consent
Exclusion Criteria:
- Participants with a clear clinical indication, contraindication, preference for or intolerance to statin, beta blocker (e.g. bradycardia), ACE inhibitor, diuretic, aspirin or clopidogrel in the judgment of the physician
- Regular use of vitamin D at doses higher than 400 IU/day
- Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or indication for vitamin D therapy
- Peptic ulcer disease, frequent dyspepsia or bleeding
- Known vascular disease. (e.g. Stroke, TIA, Angina, MI, ACS, PVD including claudication and amputation)
- Mean systolic BP below 120 mm Hg at run-in
- Symptomatic hypotension (e.g. dizziness with SBP < 110 mm Hg systolic) during the run-in phase
- Chronic liver disease or abnormal liver function, i.e. ALT or AST > 3 x ULN
- Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) > 3 x ULN.
- Severe renal impairment (serum creatinine > 264 µmol/L)
- History of malignancy affecting any organ system, except basal cell carcinoma of the skin, within the previous 5 years
- Other serious condition(s) likely to interfere with study participation or with the ability to complete the trial
- Concurrent use of any experimental pharmacological agent
- Inability to attend follow-up as required by the protocol for at least 5 years
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01646437
| Contact: Koon Teo | 905 527 4322 | tips3@phri.ca | |
| Contact: Jessica Tyrwhitt | 905 527 4322 | tips3@phri.ca |
| Canada, Ontario | |
| Hamilton Health Sciences | Not yet recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Principal Investigator: Eva Lonn | |
| India | |
| Caritas Hosptial | Recruiting |
| Kottayam, Kerala, India, 686016 | |
| Principal Investigator: Johny Joseph | |
| Principal Investigator: | Salim Yusuf | Population Health Research Institute | |
| Principal Investigator: | Prem Pais | St. John's Research Institute |
More Information
No publications provided
| Responsible Party: | Salim Yusuf's office, Executive Director - Population Health Research Institute, Professor of Medicine - McMaster University, Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01646437 History of Changes |
| Other Study ID Numbers: | TIPS-3 |
| Study First Received: | July 10, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Canada: Health Canada China: Food and Drug Administration India: Drugs Controller General of India Philippines : Food and Drug Administration |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on March 02, 2015