Clinical trial NCT01313702: Single Pill to Avert Cardiovascular Events
Official title: Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cardiovascular Disease
Keywords: polypill, compliance, cardiovascular disease
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: compliance with treatment
timeFrame: 18 months
measure: changed in blood pressure
timeFrame: 18 months
measure: changes in LDL-cholesterol levels
timeFrame: 18 months
Secondary outcomes:
measure: the main reason for non compliance with treatment
timeFrame: 18 months
measure: safety of poli pill measures by laboratorial tests
timeFrame: 18 months
measure: combined outcome
timeFrame: 18 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa - IEP - HCor
Study officials:
affiliation: Instituto de Ensino e Pesquisa - IEP - HCor
name: Otavio Berwanger, PhD
role: STUDY_DIRECTOR
References: