Cardiovascular DiseasePhase 2NCT00567307
Polypill For Prevention of Cardiovascular Disease
A Phase 2 study testing Red Heart Pill 2b (Polypill) and Standard Practice in people with Cardiovascular Disease, run by Wake Forest University Health Sciences at 3 sites in Sri Lanka.
Trial summary
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Red Heart Pill 2b (Polypill) and Standard Practice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesSri Lanka
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimated 10-year total CVD risk score > 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
- No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
- Informed consent given
Who cannot join
- Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
- Patients with secondary hypertension
- Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
- Known renal failure or impairment
- Atrial fibrillation
- ALT > 1.5 times the upper limit of normal
Show all 11Show fewer
- History of liver cirrhosis or hepatitis
- History of recent gastrointestinal bleeding (within the last year)
- Women in child bearing period
- History of life-limiting diseases or events
- Unwillingness to sign informed consent.
Trial locations and contacts
3 sites in 1 country.
Sri Lanka3 sites
The National Hospital of Sri Lanka
Colombo, Colombo10
Teaching (General) Hospital Kandy
Kandy
Teaching (General) Hospital Kegalle
Kegalle
About this study
Official title: The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.
Read the detailed description
This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits.
Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka.
Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible
- Conditions
- Cardiovascular Disease
- Being tested
- Red Heart Pill 2b (Polypill), Standard Practice
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Heart Pill 2b (Polypill)Drug
Also called Polypill
Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)
Standard PracticeOther
Also called Usual care
Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions
| Study group | Role | What they receive |
|---|---|---|
| The Red Heart Pill 2b (Polypill) (A) | Experimental | The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide Receives: Drug: Red Heart Pill 2b (Polypill) |
| Standard Practice Group (B) | Active comparator | Standard Practice Receives: Other: Standard Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the Estimated 10-year Total Cardiovascular Risk Score
Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, National Hospital of Sri Lanka
- Responsible party
- Sponsor
- Investigators
- Elsayed Z Soliman, MD, MSc, MS, Principal investigator, Wake Forest University Health SciencesShanthi Mendis, MD, FRCP, Study director, World Heath OrganizationCurt D Furberg, MD, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567307
- Sponsor's protocol ID
- IRB00004134
- Other IDs
- SLCTR/ 2007/012
- Status last verified
- Aug 2018
- First submitted
- 30 Nov 2007
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3.
PubMed 21205325
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT00567307
- Acronym / sponsor ID
- IRB00004134
- Conditions
- Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- World Health Organization, National Hospital of Sri Lanka
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.
Detailed description
This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits.
Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka.
Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Red Heart Pill 2b (Polypill) (A) | Experimental | Drug: Red Heart Pill 2b (Polypill)The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide |
| Standard Practice Group (B) | Active comparator | Other: Standard PracticeStandard Practice |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated 10-year total CVD risk score > 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
- No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
- Informed consent given
Key exclusion criteria (11 listed)
- Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
- Patients with secondary hypertension
- Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
- Known renal failure or impairment
- Atrial fibrillation
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 |
|---|---|---|
| Red Heart Pill 2b (Polypill)Also: PolypillArm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg) | Drug | The Red Heart Pill 2b (Polypill) (A) |
| Standard PracticeAlso: Usual careArm B will receive management of their CVD risk according to the usual care given to participants in similar conditions | Other | Standard Practice Group (B) |
Primary outcome
Reduction of the Estimated 10-year Total Cardiovascular Risk Score
Time frame: Six months
Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21205325Soliman EZ, Mendis S, Dissanayake WP, Somasundaram NP, Gunaratne PS, Jayasingne IK, Furberg CD. A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization. Trials. 2011 Jan 5;12:3. doi: 10.1186/1745-6215-12-3.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Disease
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
Elsayed Z Soliman, MD, MSc, MS principal investigator
Wake Forest University Health Sciences
Shanthi Mendis, MD, FRCP study director
World Heath Organization
Curt D Furberg, MD, PhD study chair
Wake Forest University Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Red Heart Pill 2b (Polypill) and Standard Practice in people with Cardiovascular Disease, run by Wake Forest University Health Sciences at 3 sites in Sri Lanka.
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 3 inclusion and 11 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sri Lanka. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction of the Estimated 10-year Total Cardiovascular Risk Score (time frame: Six months). 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 NCT00567307, which also lists 1 linked publication.
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 10 Sep 2018.