Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Pill to Avert Cardiovascular Events (SPACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01313702
Recruitment Status : Unknown
Verified March 2012 by Hospital do Coracao.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2011
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: polipillV1 Drug: polipillV2 Drug: usual care Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial
Study Start Date : October 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : July 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. compliance with treatment [ Time Frame: 18 months ]
  2. changed in blood pressure [ Time Frame: 18 months ]
  3. changes in LDL-cholesterol levels [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. the main reason for non compliance with treatment [ Time Frame: 18 months ]
  2. safety of poli pill measures by laboratorial tests [ Time Frame: 18 months ]
    hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).

  3. combined outcome [ Time Frame: 18 months ]
    compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313702


Contacts
Layout table for location contacts
Contact: Otavio Berwanger, PhD +55 11 30536611 ext 8203 oberwanger@hcor.com.br

Locations
Layout table for location information
Brazil
Instituto de Ensino e Pesquisa - IEP - HCor
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
Layout table for investigator information
Study Director: Otavio Berwanger, PhD Instituto de Ensino e Pesquisa - IEP - HCor
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01313702    
Other Study ID Numbers: IEP001/2011
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by Hospital do Coracao:
polypill, compliance, cardiovascular disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Atenolol
Lisinopril
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents