Single Pill to Avert Cardiovascular Events (SPACE)
This study is not yet open for participant recruitment.
Verified March 2012 by Hospital do Coracao
Sponsor:
Hospital do Coracao
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
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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:
|
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
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 June 18, 2013