Cardiovascular Disease | Single Pill to Avert Cardiovascular Events
Cardiovascular Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:polipillV1polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
Drug:polipillV2Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
Drug:usual carethe drugs used in clinical practice, defined by physician
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
polipillV1poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
polipillV2Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
Start Date: October 2012
Completed Date: July 2014
Phase: Phase 3
Primary Outcome: compliance with treatment
Secondary Outcome: the main reason for non compliance with treatment
Study sponsors, principal investigator, and references
Principal Investigator: Otavio Berwanger, PhD
Lead Sponsor: Hospital do Coracao