Trial | NCT01313702  Report issue

Title

Single Pill to Avert Cardiovascular Events
Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Oct 31
2012
Primary Completion
Apr 30
2014
Anticipated
Study Completion
Jul 31
2014
Anticipated
Last Update
Sep 21
2022

Drug polipillV1

polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg

  • Other names: no other name

Drug polipillV2

Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.

  • Other names: no other name

Drug usual care

the drugs used in clinical practice, defined by physician

  • Other names: lisinopril, simvastatin, atenolol, hidrochlorotiazide, acetylsalicilic acid

polipillV1 Experimental

poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg

polipillV2 Experimental

Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.

usual care Active Comparator

Criteria 

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.
No Results Posted