Single Pill to Avert Cardiovascular Events

Cardiovascular Disease Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01313702
• Other study ID #: IEP001/2011
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2012
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• polipillV1
polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
• polipillV2
Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
• usual care
the drugs used in clinical practice, defined by physician

Locations

Country	Name	City	State
Brazil	Instituto de Ensino e Pesquisa - IEP - HCor	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance with treatment		18 months
Primary	changed in blood pressure		18 months
Primary	changes in LDL-cholesterol levels		18 months
Secondary	the main reason for non compliance with treatment		18 months
Secondary	safety of poli pill measures by laboratorial tests	hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).	18 months
Secondary	combined outcome	compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.	18 months