Nctid:
NCT00000510
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D003327", "term"=>"Coronary Disease"}, {"id"=>"D017202", "term"=>"Myocardial Ischemia"}, {"id"=>"D000787", "term"=>"Angina Pectoris"}], "ancestors"=>[{"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002637", "term"=>"Chest Pain"}, {"id"=>"D010146", "term"=>"Pain"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M6546", "name"=>"Coronary Artery Disease", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "asFound"=>"Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M19506", "name"=>"Myocardial Ischemia", "asFound"=>"Myocardial Ischemia", "relevance"=>"HIGH"}, {"id"=>"M6549", "name"=>"Coronary Disease", "asFound"=>"Coronary Disease", "relevance"=>"HIGH"}, {"id"=>"M4117", "name"=>"Angina Pectoris", "asFound"=>"Angina Pectoris", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M5882", "name"=>"Chest Pain", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D001241", "term"=>"Aspirin"}, {"id"=>"D004176", "term"=>"Dipyridamole"}], "ancestors"=>[{"id"=>"D000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D005343", "term"=>"Fibrinolytic Agents"}, {"id"=>"D050299", "term"=>"Fibrin Modulating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D010975", "term"=>"Platelet Aggregation Inhibitors"}, {"id"=>"D016861", "term"=>"Cyclooxygenase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D058633", "term"=>"Antipyretics"}, {"id"=>"D010726", "term"=>"Phosphodiesterase Inhibitors"}, {"id"=>"D014665", "term"=>"Vasodilator Agents"}], "browseLeaves"=>[{"id"=>"M4548", "name"=>"Aspirin", "asFound"=>"Phase II", "relevance"=>"HIGH"}, {"id"=>"M13865", "name"=>"Platelet Aggregation Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7358", "name"=>"Dipyridamole", "asFound"=>"Curettes", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M8473", "name"=>"Fibrinolytic Agents", "relevance"=>"LOW"}, {"id"=>"M19209", "name"=>"Cyclooxygenase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M29176", "name"=>"Antipyretics", "relevance"=>"LOW"}, {"id"=>"M13629", "name"=>"Phosphodiesterase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17412", "name"=>"Vasodilator Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antipyretics", "abbrev"=>"Antipy"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Fibrinolytic Agents", "abbrev"=>"FiAg"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1983-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2005-03", "completionDateStruct"=>{"date"=>"1988-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-11-25", "studyFirstSubmitDate"=>"1999-10-27", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-26", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Angina Pectoris", "Cardiovascular Diseases", "Coronary Disease", "Heart Diseases", "Myocardial Ischemia"]}, "descriptionModule"=>{"briefSummary"=>"To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.", "detailedDescription"=>"BACKGROUND:\n\nBy dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery.\n\nBalloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis.\n\nDESIGN NARRATIVE:\n\nRandomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo.\n\nThe study completion date listed in this record was obtained from the Query/View/Report (QVR) System."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients to age 80 with angina pectoris."}, "identificationModule"=>{"nctId"=>"NCT00000510", "briefTitle"=>"Platelet-Inhibitor Drug Trial in Coronary Angioplasty", "organization"=>{"class"=>"NIH", "fullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "orgStudyIdInfo"=>{"id"=>"29"}, "secondaryIdInfos"=>[{"id"=>"R01HL031025", "link"=>"https://reporter.nih.gov/quickSearch/R01HL031025", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"aspirin", "type"=>"DRUG"}, {"name"=>"dipyridamole", "type"=>"DRUG"}, {"name"=>"angioplasty, transluminal, percutaneous coronary", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"James Chesebro", "affiliation"=>"Mayo Foundation"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
