NCT01313702

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 21, 2022

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

March 10, 2011

Last Update Submit

September 20, 2022

Conditions

Cardiovascular Disease

Keywords

polypill, compliance, cardiovascular disease

Outcome Measures

Primary Outcomes (3)

  • compliance with treatment

    18 months

  • changed in blood pressure

    18 months

  • changes in LDL-cholesterol levels

    18 months

Secondary Outcomes (3)

  • the main reason for non compliance with treatment

    18 months

  • safety of poli pill measures by laboratorial tests

    18 months

  • combined outcome

    18 months

Study Arms (3)

polipillV1

EXPERIMENTAL

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

Drug: polipillV1

polipillV2

EXPERIMENTAL

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

Drug: polipillV2

usual care

ACTIVE COMPARATOR
Drug: usual care

Interventions

polipillV1DRUG

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

Also known as: no other name
polipillV1
polipillV2DRUG

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

Also known as: no other name
polipillV2
usual careDRUG

the drugs used in clinical practice, defined by physician

Also known as: lisinopril, simvastatin, atenolol, hidrochlorotiazide, acetylsalicilic acid
usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ensino e Pesquisa - IEP - HCor

São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

Cardiovascular DiseasesPatient Compliance

Interventions

LisinoprilSimvastatinAtenolol

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAmines

Study Officials

  • Otavio Berwanger, PhD

    Instituto de Ensino e Pesquisa - IEP - HCor

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 14, 2011

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

September 21, 2022

Record last verified: 2012-03

Locations

BR(1)