Single Pill to Avert Cardiovascular Events

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: polipillV1
* Drug: polipillV2
* Drug: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polipillV1<br>poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg | Drug: polipillV1<br>* polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg<br>* Other names: no other name;|
| Experimental: polipillV2<br>Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. | Drug: polipillV2<br>* Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.<br>* Other names: no other name;|
| Active Comparator: usual care<br> | Drug: usual care<br>* the drugs used in clinical practice, defined by physician<br>* Other names: acetylsalicilic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance with treatment |  | 18 months | 
| changed in blood pressure |  | 18 months | 
| changes in LDL-cholesterol levels |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the main reason for non compliance with treatment |  | 18 months | 
| safety of poli pill measures by laboratorial tests | hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine). | 18 months | 
| combined outcome | compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polypill, compliance, cardiovascular disease