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.
Drug: usual care
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01313702
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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)
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)
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.
All locations for NCT01313702
Instituto de Ensino e Pesquisa - IEP - HCor
Sao Paulo, Brazil, 04005-000
View full eligibility
Tris trial is registered with FDA with number: NCT01313702. The sponsor of the trial is Hospital do Coracao and it is looking for 2000 volunteers for the current phase.
Official trial title: Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
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