Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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polipillV1
poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipillV1
polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipillV2
Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
polipillV2
Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
usual care
usual care
the drugs used in clinical practice, defined by physician
Interventions
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polipillV1
polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipillV2
Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
usual care
the drugs used in clinical practice, defined by physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
* 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.
18 Years
ALL
Yes
Sponsors
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Hospital do Coracao
OTHER
Responsible Party
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Principal Investigators
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Otavio Berwanger, PhD
Role: STUDY_DIRECTOR
Instituto de Ensino e Pesquisa - IEP - HCor
Locations
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Instituto de Ensino e Pesquisa - IEP - HCor
São Paulo, , Brazil
Countries
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Other Identifiers
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IEP001/2011
Identifier Type: -
Identifier Source: org_study_id
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