Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT01313702
Status:
WITHDRAWN
Last Update Posted:
2022-09-21
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Pill to Avert Cardiovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance with treatment', 'timeFrame': '18 months'}, {'measure': 'changed in blood pressure', 'timeFrame': '18 months'}, {'measure': 'changes in LDL-cholesterol levels', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'the main reason for non compliance with treatment', 'timeFrame': '18 months'}, {'measure': 'safety of poli pill measures by laboratorial tests', 'timeFrame': '18 months', 'description': 'hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine).'}, {'measure': 'combined outcome', 'timeFrame': '18 months', 'description': 'compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polypill, compliance, cardiovascular disease'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age ≥ 18 years old;\n* Patient that could written informed consent;\n* Patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:\n* Patients with previous Coronary Artery Disease (miocardial Infarction, estable or instable angina pectoris or coronary revascularization procedures);\n* 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);\n* Patients with previous brain ischemia (stroke or transient ischemic attack)\n* Patients with confirmed previous peripheral arterial disease (Coronary Artery Bypass procedures or angioplasty or amputation due peripheral arterial disease)\n* 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)\n\nExclusion Criteria:\n\n* contraindication for any of the polipill\n* 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\n* Acute clinical conditions/ surgeries\n* Psychiatry clinical conditions(for example, schizophrenia, serious depression)\n* pregnant or lactation women\n* women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)\n* liver siseases (AST/ALT/FA upon 3 x normal superior limits / bilirrubin upon 1,5 X normal superior limits / diagnosed Liver Cirrhosis\n* Renal disfunction (any laboratorial exams upon 3 x normal superior limits)\n* Previous participation on other clinical trial\n* The participant is unable or refuse to give informed consent.'}, 'identificationModule': {'nctId': 'NCT01313702', 'acronym': 'SPACE', 'briefTitle': 'Single Pill to Avert Cardiovascular Events', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Effect of Polipill on Patients at High Cardiovascular Risk : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IEP001/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'polipillV1', 'description': 'poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg', 'interventionNames': ['Drug: polipillV1']}, {'type': 'EXPERIMENTAL', 'label': 'polipillV2', 'description': 'Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.', 'interventionNames': ['Drug: polipillV2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'interventionNames': ['Drug: usual care']}], 'interventions': [{'name': 'polipillV1', 'type': 'DRUG', 'otherNames': ['no other name'], 'description': 'polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg', 'armGroupLabels': ['polipillV1']}, {'name': 'polipillV2', 'type': 'DRUG', 'otherNames': ['no other name'], 'description': 'Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.', 'armGroupLabels': ['polipillV2']}, {'name': 'usual care', 'type': 'DRUG', 'otherNames': ['lisinopril', 'simvastatin', 'atenolol', 'hidrochlorotiazide', 'acetylsalicilic acid'], 'description': 'the drugs used in clinical practice, defined by physician', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04005-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Ensino e Pesquisa - IEP - HCor', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Otavio Berwanger, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto de Ensino e Pesquisa - IEP - HCor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}