Single Pill to Avert Cardiovascular Events (SPACE)

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

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 Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: polipillV1; Drug: polipillV2; Drug: usual care

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04005-000
    • Instituto de Ensino e Pesquisa - IEP - HCor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: usual care	Drug: usual care; the drugs used in clinical practice, defined by physician; Other Names: simvastatin; lisinopril; atenolol; hidrochlorotiazide; acetylsalicilic acid
Experimental: polipillV1; poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg	Drug: polipillV1; polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg; Other Names: no other name
Experimental: polipillV2; Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.	Drug: polipillV2; Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compliance with treatment	18 months
changed in blood pressure	18 months
changes in LDL-cholesterol levels	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the main reason for non compliance with treatment		18 months
safety of poli pill measures by laboratorial tests	hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).	18 months
combined outcome	compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.	18 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Study Director: Otavio Berwanger, PhD, Instituto de Ensino e Pesquisa - IEP - HCor

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: polypill, compliance, cardiovascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Simvastatin; Lisinopril; Atenolol
• Other Study ID Numbers: IEP001/2011