Single Pill to Avert Cardiovascular Events (SPACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hospital do Coracao.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01313702
First received: March 10, 2011
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: polipillV1
Drug: polipillV2
Drug: usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • compliance with treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • changed in blood pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • changes in LDL-cholesterol levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the main reason for non compliance with treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • safety of poli pill measures by laboratorial tests [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).

  • combined outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.


Estimated Enrollment: 2000
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: no other name
Active Comparator: usual care Drug: usual care
the drugs used in clinical practice, defined by physician
Other Names:
  • lisinopril
  • simvastatin
  • atenolol
  • hidrochlorotiazide
  • acetylsalicilic acid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313702

Contacts
Contact: Otavio Berwanger, PhD +55 11 30536611 ext 8203 oberwanger@hcor.com.br

Locations
Brazil
Instituto de Ensino e Pesquisa - IEP - HCor Not yet recruiting
Sao Paulo, Brazil, 04005-000
Contact: Otavio Berwanger, PhD    +55 11 30536611 ext 8203    oberwanger@hcor.com.br   
Principal Investigator: Otavio Berwanger, PhD         
Sponsors and Collaborators
Hospital do Coracao
Investigators
Study Director: Otavio Berwanger, PhD Instituto de Ensino e Pesquisa - IEP - HCor
  More Information

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01313702     History of Changes
Other Study ID Numbers: IEP001/2011
Study First Received: March 10, 2011
Last Updated: March 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital do Coracao:
polypill, compliance, cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Atenolol
Hydrochlorothiazide
Lisinopril
Simvastatin
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on July 24, 2014