Cardiovascular DiseasePhase 3TIPS-3NCT01646437
The International Polycap Study 3 (TIPS-3)
A Phase 3 study testing Polycap, Aspirin and Vitamin D in people with Cardiovascular Disease and Fractures, run by Population Health Research Institute at 9 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Disease, Fractures, Cancers
- What is being tested?
- Polycap, Aspirin and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,793 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Jun 2012to 30 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥ 50 years and women aged ≥ 55 years with an INTERHEART risk score ≥ 10 OR men and women aged ≥ 65 years with an INTERHEART risk score of ≥5.
- Provision of informed consent
Who cannot join
- 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 per day.
- Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or indication for vitamin D therapy.
- Peptic ulcer disease, frequent dyspepsia or bleeding.
- Expected long term use of anticoagulants
- Known vascular disease. (e.g., Stroke, TIA, Angina, MI, ACS, PVD including claudication and amputation).
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- Mean systolic BP (using 2 automatic readings) 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.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Philippines1 site
Adult Medicine & Medical Research Unit, Philippine General Hospital
Manila
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Fractures, Cancers
- Medical subject headings
- Cardiovascular Diseases, Fractures, Bone, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolycapDrug
Polycap (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) taken once daily
AspirinDrug
Also called enteric coated aspirin
75 mg daily
Vitamin DDrug
Also called cholecalciferol
60,000 IU monthly
Matching PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Polycap vs. matching placebo | Experimental | Polycap is a once daily capsule containing thiazide (25mg), atenolol (100mg), ramipril (10mg) and simvastatin (40mg) vs. matching placebo Receives: Drug: Polycap; Drug: Matching Placebo |
| Aspirin vs. matching placebo | Experimental | Once daily 75mg tablet of Aspirin vs. matching placebo Receives: Drug: Aspirin; Drug: Matching Placebo |
| Vitamin D vs. matching placebo | Experimental | Monthly oral dosage of 60,000IU vs. matching placebo Receives: Drug: Vitamin D; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycap Primary Objective
To determine whether the Polycap reduces the risk of the composite outcome of CVD events which includes major CVD (CV death, non-fatal stroke, non-fatal MI), plus heart failure, resuscitated cardiac arrest, or arterial revascularization compared to placebo.
Measured: Participants will be followed for an average of 4.25 years
Aspirin Primary Objective
To determine whether aspirin reduces the risk of composite outcome of major CV events (CV death, non-fatal MI or non-fatal stroke,) compared to its placebo.
Measured: Participants will be followed for an average of 4.25 years
Vitamin D Primary Objective
To determine whether vitamin D reduces the risk of fractures compared to its placebo.
Measured: Participants will be followed for an average of 4.25 years
Combined Effects of Polycap and Aspirin on CVD Events
To determine the combined effect of aspirin and the Polycap (i.e. double treatment) on major CV events (CV death, non-fatal MI or non-fatal stroke), heart failure, resuscitated cardiac arrest, or arterial revascularization compared to double-placebo.
Measured: Participants will be followed for an average of 4.25 years
Secondary outcomes (5)
Polycap Secondary Objective
To determine whether the Polycap reduces the risk of the composite of CV death, non-fatal stroke, and non-fatal MI compared to its placebo.To determine whether the Polycap reduces the risk of the composite outcome of major CVD (CV death, non- fatal stroke, non-fatal myocardial infarction [MI]), heart failure, resuscitated cardiac arrest, arterial revascularization, or angina with evidence of ischemia.
Measured: Participants will be followed for an average of 4.25 years
Aspirin Secondary Objective
To determine whether a daily aspirin reduces the risk of the composite outcome of major CV events (CV death, non-fatal MI or non-fatal stroke) and cancers compared to its placebo.
Measured: Participants will be followed for an average of 4.25 years
Vitamin D Secondary Objective
To determine whether vitamin D reduces the risk of the composite outcome of CV events, fractures and cancers, and the risk of falls compared to its placebo.
Measured: Participants will be followed for an average of 4.25 years
Combined Effects of Polycap and Aspirin on CVD Events Secondary Outcome A
To determine whether the Polycap and aspirin reduces the risk of the composite of CV death, non-fatal stroke, and non-fatal MI compared to double placebo.
Measured: Participants will be followed for an average of 4.25 years
Combined Effects of Polycap and Aspirin on CVD Events Secondary Outcome B
To determine whether the Polycap and aspirin reduces the risk of the composite outcome of major CVD (CV death, non- fatal stroke, non-fatal myocardial infarction [MI]), heart failure, resuscitated cardiac arrest, arterial revascularization, or angina with evidence of ischemia, compared to double-placebo
Measured: Participants will be followed for an average of 4.25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completion30 Jun 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cadila Pharnmaceuticals, Wellcome Trust, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Salim Yusuf's office, Population Health Research Institute
- Investigators
- Salim Yusuf, Principal investigator, Population Health Research InstitutePrem Pais, Principal investigator, St. John's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646437
- Sponsor's protocol ID
- TIPS-3
- Acronym
- TIPS-3
- Status last verified
- Sep 2021
- First submitted
- 10 Jul 2012
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Joseph P, Pais P, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder SH, Christou C, Dagenais G, Tyrwhitt J, Bosch J, Dans A, Yusuf S; International Polycap Study (TIPS)-3 Investigators. Vitamin D supplementation and adverse skeletal and non-skeletal outcomes in individuals at increased cardiovascular risk: Results from the International Polycap Study (TIPS)-3 randomized controlled trial. Nutr Metab Cardiovasc Dis. 2023 Feb;33(2):434-440. doi: 10.1016/j.numecd.2022.11.001. Epub 2022 Nov 15.
PubMed 36604262Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.
PubMed 33186492Joseph P, Pais P, Dans AL, Bosch J, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Talukder S, Gamra H, Yeates K, Lopez PC, Tyrwhitt J, Gao P, Teo K, Yusuf S; TIPS-3 Investigators. The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct. Am Heart J. 2018 Dec;206:72-79. doi: 10.1016/j.ahj.2018.07.012. Epub 2018 Aug 2.
PubMed 30342297
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01646437
- Acronym / sponsor ID
- TIPS-3 / TIPS-3
- Conditions
- Cardiovascular Disease, Fractures, Cancers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,793 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Cadila Pharnmaceuticals, Wellcome Trust, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Study start
- Jun 2012
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polycap vs. matching placebo | Experimental | Drug: Polycap, Drug: Matching PlaceboPolycap is a once daily capsule containing thiazide (25mg), atenolol (100mg), ramipril (10mg) and simvastatin (40mg) vs. matching placebo |
| Aspirin vs. matching placebo | Experimental | Drug: Aspirin, Drug: Matching PlaceboOnce daily 75mg tablet of Aspirin vs. matching placebo |
| Vitamin D vs. matching placebo | Experimental | Drug: Vitamin D, Drug: Matching PlaceboMonthly oral dosage of 60,000IU vs. matching placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged ≥ 50 years and women aged ≥ 55 years with an INTERHEART risk score ≥ 10 OR men and women aged ≥ 65 years with an INTERHEART risk score of ≥5.
- Provision of informed consent
Key exclusion criteria (15 listed)
- 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 per day.
- Hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication or indication for vitamin D therapy.
- Peptic ulcer disease, frequent dyspepsia or bleeding.
- Expected long term use of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolycapPolycap (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) taken once daily | Drug | Polycap vs. matching placebo |
| AspirinAlso: enteric coated aspirin75 mg daily | Drug | Aspirin vs. matching placebo |
| Vitamin DAlso: cholecalciferol60,000 IU monthly | Drug | Vitamin D vs. matching placebo |
| Matching PlaceboMatching Placebo | Drug | Aspirin vs. matching placebo, Polycap vs. matching placebo, Vitamin D vs. matching placebo |
Primary outcome
Polycap Primary Objective
Time frame: Participants will be followed for an average of 4.25 years
To determine whether the Polycap reduces the risk of the composite outcome of CVD events which includes major CVD (CV death, non-fatal stroke, non-fatal MI), plus heart failure, resuscitated cardiac arrest, or arterial revascularization compared to placebo.
Aspirin Primary Objective
Time frame: Participants will be followed for an average of 4.25 years
To determine whether aspirin reduces the risk of composite outcome of major CV events (CV death, non-fatal MI or non-fatal stroke,) compared to its placebo.
Vitamin D Primary Objective
Time frame: Participants will be followed for an average of 4.25 years
To determine whether vitamin D reduces the risk of fractures compared to its placebo.
Combined Effects of Polycap and Aspirin on CVD Events
Time frame: Participants will be followed for an average of 4.25 years
To determine the combined effect of aspirin and the Polycap (i.e. double treatment) on major CV events (CV death, non-fatal MI or non-fatal stroke), heart failure, resuscitated cardiac arrest, or arterial revascularization compared to double-placebo.
5 secondary outcomes
Polycap Secondary Objective
Time frame: Participants will be followed for an average of 4.25 years
Aspirin Secondary Objective
Time frame: Participants will be followed for an average of 4.25 years
Vitamin D Secondary Objective
Time frame: Participants will be followed for an average of 4.25 years
Combined Effects of Polycap and Aspirin on CVD Events Secondary Outcome A
Time frame: Participants will be followed for an average of 4.25 years
Combined Effects of Polycap and Aspirin on CVD Events Secondary Outcome B
Time frame: Participants will be followed for an average of 4.25 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 36604262Joseph P, Pais P, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder SH, Christou C, Dagenais G, Tyrwhitt J, Bosch J, Dans A, Yusuf S; International Polycap Study (TIPS)-3 Investigators. Vitamin D supplementation and adverse skeletal and non-skeletal outcomes in individuals at increased cardiovascular risk: Results from the International Polycap Study (TIPS)-3 randomized controlled trial. Nutr Metab Cardiovasc Dis. 2023 Feb;33(2):434-440. doi: 10.1016/j.numecd.2022.11.001. Epub 2022 Nov 15.
- Derived from this study: PubMed 33186492Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.
- Derived from this study: PubMed 30342297Joseph P, Pais P, Dans AL, Bosch J, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Talukder S, Gamra H, Yeates K, Lopez PC, Tyrwhitt J, Gao P, Teo K, Yusuf S; TIPS-3 Investigators. The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct. Am Heart J. 2018 Dec;206:72-79. doi: 10.1016/j.ahj.2018.07.012. Epub 2018 Aug 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salim Yusuf principal investigator
Population Health Research Institute
Prem Pais principal investigator
St. John's Research Institute
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polycap, Aspirin and Vitamin D in people with Cardiovascular Disease and Fractures, run by Population Health Research Institute at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Bangladesh, Canada, Colombia, India, Indonesia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polycap Primary Objective (time frame: Participants will be followed for an average of 4.25 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01646437, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.