Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 1:43 PM
Study NCT ID:
NCT00620204
Status:
UNKNOWN
Last Update Posted:
2009-04-06
First Post:
2008-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Atorvastatin to Treat Variant Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000788', 'term': 'Angina Pectoris, Variant'}], 'ancestors': [{'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2008-02-10', 'studyFirstSubmitQcDate': '2008-02-10', 'lastUpdatePostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ergonovine provocation test 24hrs later after admission', 'timeFrame': '1 year later'}], 'secondaryOutcomes': [{'measure': 'Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)', 'timeFrame': '1year later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atorvastatin', 'Angina Pectoris, Variant', 'endothelial dysfunction'], 'conditions': ['Angina Pectoris, Variant']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effect of statin treatment for vasospastic angina.', 'detailedDescription': 'Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.\n\nImpaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.\n\nSo, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)\n* Normal or insignificant lesion (diameter stenosis \\<50%) on coronary angiography\n\nExclusion Criteria:\n\n* Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal\n* Significant lesion( diameter stenosis ≥50%) documented in coronary angiography\n* Pregnancy\n* Prior percutaneous coronary intervention or coronary artery bypass surgery\n* Previous statin use\n* Impaired renal function with serum creatinine ≥ 2.0 mg/dl\n* Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)\n* Myopathy'}, 'identificationModule': {'nctId': 'NCT00620204', 'acronym': 'ESAVA', 'briefTitle': 'Efficacy Study of Atorvastatin to Treat Variant Angina', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Efficacy Study of Atorvastatin to Treat Variant Angina', 'orgStudyIdInfo': {'id': '2008-01-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Atorvastatin group', 'interventionNames': ['Drug: atorvastatin']}, {'type': 'NO_INTERVENTION', 'label': 'B', 'description': 'Control group'}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor®'], 'description': 'atorvastatin 40mg qd for 1 year', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyun-chul Gwon, MD,PhD', 'role': 'CONTACT', 'email': 'hcgwon@smc.samsung.co.kr', 'phone': '82-2-3410-3418'}], 'overallOfficials': [{'name': 'Hyun-chul Gwon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HC Gwon, MD,PhD / Professor', 'oldOrganization': 'Samsung Medical Center'}}}}