The International Polycap Study 3 (TIPS-3) (TIPS-3)
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| ClinicalTrials.gov Identifier: NCT01646437 |
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Recruitment Status :
Active, not recruiting
First Posted : July 20, 2012
Last Update Posted : September 30, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Disease Fractures Cancers | Drug: Polycap Drug: Aspirin Drug: Vitamin D Drug: Matching Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5713 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | June 2012 |
| Estimated Primary Completion Date : | June 2020 |
| Estimated Study Completion Date : | March 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Polycap vs. matching placebo
Polycap is a once daily capsule containing thiazide (25mg), atenolol (100mg), ramipril (10mg) and simvastatin (40mg) vs. matching placebo
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Drug: Polycap
Polycap (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) taken once daily Drug: Matching Placebo Matching Placebo |
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Experimental: Aspirin vs. matching placebo
Once daily 75mg tablet of Aspirin vs. matching placebo
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Drug: Aspirin
75 mg daily
Other Name: enteric coated aspirin Drug: Matching Placebo Matching Placebo |
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Experimental: Vitamin D vs. matching placebo
Monthly oral dosage of 60,000IU vs. matching placebo
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Drug: Vitamin D
60,000 IU monthly
Other Name: cholecalciferol Drug: Matching Placebo Matching Placebo |
- 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 ]
- 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 ]
- Risk of fractures in participants taking vitamin D versus placebo [ Time Frame: Participants will be followed for an average of 5 years ]
- 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 ]
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646437
| Bangladesh | |
| Eminence | |
| Dhaka, Bangladesh | |
| Canada, Ontario | |
| Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Colombia | |
| Fundaction Oftamologica De Santander (FOSCAL) | |
| Bucaramanga, Colombia | |
| India | |
| St. John's Medical College Hospital | |
| Bangalore, India | |
| Malaysia | |
| Centre For Translational Research & Epidemiology (CenTRE) | |
| Selangor, Malaysia | |
| Philippines | |
| Adult Medicine & Medical Research Unit, Philippine General Hospital | |
| Manila, Philippines | |
| Tanzania | |
| Pamoja Tunaweza Women's Centre | |
| Moshi, Tanzania | |
| Tunisia | |
| Fattouma Bourguiba University Hospital | |
| Monastir, Tunisia | |
| Principal Investigator: | Salim Yusuf | Population Health Research Institute | |
| Principal Investigator: | Prem Pais | St. John's Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Other Study ID Numbers: |
TIPS-3 |
| First Posted: | July 20, 2012 Key Record Dates |
| Last Update Posted: | September 30, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Cardiovascular Diseases Aspirin Vitamin D Ergocalciferols Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |