Cardiovascular DiseasePhase 3SPACENCT01313702
Single Pill to Avert Cardiovascular Events
A Phase 3 study testing polipillV1 and polipillV2 in people with Cardiovascular Disease, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- polipillV1 and polipillV2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Jul 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age ≥ 18 years old;
- Patient that could written informed consent;
- Patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
- Patients with previous Coronary Artery Disease (miocardial Infarction, estable or instable angina pectoris or coronary revascularization procedures);
- Patients with previous miocardial Infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,patological electrocardiogram and elevation of cardiac enzymes- CK-MB and/or troponin);
- Patients with previous brain ischemia (stroke or transient ischemic attack)
- Patients with confirmed previous peripheral arterial disease (Coronary Artery Bypass procedures or angioplasty or amputation due peripheral arterial disease)
- Patients with no established cardiovascular disease but at high cardiovascular risk, defined as 15% or more in 5 years (using the Anderson Framingham scale, 1991)
Who cannot join
- contraindication for any of the polipill
- If the physician opinion is that terapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension [degree 3], malignant hypertension or renal insufficiency
- Acute clinical conditions/ surgeries
- Psychiatry clinical conditions(for example, schizophrenia, serious depression)
- pregnant or lactation women
- women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)
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- liver siseases (AST/ALT/FA upon 3 x normal superior limits / bilirrubin upon 1,5 X normal superior limits / diagnosed Liver Cirrhosis
- Renal disfunction (any laboratorial exams upon 3 x normal superior limits)
- Previous participation on other clinical trial
- The participant is unable or refuse to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
The purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease.
- Conditions
- Cardiovascular Disease
- Being tested
- polipillV1, polipillV2, usual care
- Keywords
- polypill, compliance, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polipillV1Drug
Also called no other name
polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipillV2Drug
Also called no other name
Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
usual careDrug
Also called lisinopril, simvastatin, atenolol, hidrochlorotiazide
the drugs used in clinical practice, defined by physician
| Study group | Role | What they receive |
|---|---|---|
| polipillV1 | Experimental | poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg Receives: Drug: polipillV1 |
| polipillV2 | Experimental | Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. Receives: Drug: polipillV2 |
| usual care | Active comparator | Not described Receives: Drug: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance with treatment
Measured: 18 months
changed in blood pressure
Measured: 18 months
changes in LDL-cholesterol levels
Measured: 18 months
Secondary outcomes (3)
the main reason for non compliance with treatment
Measured: 18 months
safety of poli pill measures by laboratorial tests
hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).
Measured: 18 months
combined outcome
compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startOct 2012
- Primary completionApr 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Otavio Berwanger, PhD, Study director, Instituto de Ensino e Pesquisa - IEP - HCor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313702
- Sponsor's protocol ID
- IEP001/2011
- Acronym
- SPACE
- Status last verified
- Mar 2012
- First submitted
- 10 Mar 2011
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01313702
- Acronym / sponsor ID
- SPACE / IEP001/2011
- Conditions
- Cardiovascular Disease
- Keywords
- polypill, compliance, cardiovascular disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Mar 2011 (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 purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| polipillV1 | Experimental | Drug: polipillV1poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg |
| polipillV2 | Experimental | Drug: polipillV2Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. |
| usual care | Active comparator | Drug: usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults age ≥ 18 years old;
- Patient that could written informed consent;
- Patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
- Patients with previous Coronary Artery Disease (miocardial Infarction, estable or instable angina pectoris or coronary revascularization procedures);
- Patients with previous miocardial Infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,patological electrocardiogram and elevation of cardiac enzymes- CK-MB and/or troponin);
Key exclusion criteria (10 listed)
- contraindication for any of the polipill
- If the physician opinion is that terapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension [degree 3], malignant hypertension or renal insufficiency
- Acute clinical conditions/ surgeries
- Psychiatry clinical conditions(for example, schizophrenia, serious depression)
- pregnant or lactation women
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 |
|---|---|---|
| polipillV1Also: no other namepolipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg | Drug | polipillV1 |
| polipillV2Also: no other namePolipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. | Drug | polipillV2 |
| usual careAlso: lisinopril, simvastatin, atenolol, hidrochlorotiazidethe drugs used in clinical practice, defined by physician | Drug | usual care |
Primary outcome
compliance with treatment
Time frame: 18 months
changed in blood pressure
Time frame: 18 months
changes in LDL-cholesterol levels
Time frame: 18 months
3 secondary outcomes
the main reason for non compliance with treatment
Time frame: 18 months
safety of poli pill measures by laboratorial tests
Time frame: 18 months
combined outcome
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
Otavio Berwanger, PhD study director
Instituto de Ensino e Pesquisa - IEP - HCor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing polipillV1 and polipillV2 in people with Cardiovascular Disease, run by Hospital do Coracao at 1 site in Brazil.
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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
compliance with treatment (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.