Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01295567
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2011-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004176', 'term': 'Dipyridamole'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HS-troponin-I', 'timeFrame': 'within 72 hours after CABG.', 'description': 'high sensitivity cardiac troponin-I'}], 'secondaryOutcomes': [{'measure': 'duration of inotropic support', 'timeFrame': 'within three days after CABG'}, {'measure': 'duration of IC stay', 'timeFrame': 'within three days after CABG'}, {'measure': 'drain production', 'timeFrame': '24 hours after surgery and total drain production within three days after surgery', 'description': 'thoracic drain production after CABG'}, {'measure': 'post-ischemic recovery of contractile function', 'timeFrame': 'until 4 hours after harvesting', 'description': 'The right atrial appendage is harvested during cardiac surgery before the introduction of the extracorporal circulation. Two atrial trabeculae are dissected, suspended in an organ bath, and linked to a force transducer. after equilibration and baseline measurement, simulated ischemia and reperfusion influences contractile force recovery'}, {'measure': 'Renal damage', 'timeFrame': 'Within three days after CABG', 'description': 'biomarkers for renal failure will be detemined in blood and urine before and after CABG'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ischemia reperfusion injury', 'CABG', 'dipyridamole', 'HS-troponin-I'], 'conditions': ['Cardiovascular Disease', 'Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '25773594', 'type': 'DERIVED', 'citation': 'El Messaoudi S, Wouters CW, van Swieten HA, Pickkers P, Noyez L, Kievit PC, Abbink EJ, Rasing-Hoogveld A, Bouw TP, Peters JG, Coenen MJ, Donders AR, Riksen NP, Rongen GA. Effect of dipyridamole on myocardial reperfusion injury: A double-blind randomized controlled trial in patients undergoing elective coronary artery bypass surgery. Clin Pharmacol Ther. 2016 Apr;99(4):381-9. doi: 10.1002/cpt.106. Epub 2015 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Rationale:\n\nDue to western lifestyle human coronary arteries are prone to develop atherosclerotic plaques. Hence the heart is an important target organ for atherothrombotic complications: myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate symptoms and decrease mortality in these patients, myocardial revascularisation is recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe atherosclerotic disease of all three coronary arteries or the left main stem coronary artery. Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke, or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or event in secondary prevention after cerebrovascular disease. The investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I release in patients who were pretreated with dipyridamole.\n\nObjective: To study the effect of oral pretreatment with dipyridamole on high sensitivity (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole pretreatment on renal injury and post-ischemic recovery of contractile function (measured ex-vivo).\n\nHypothesis:\n\nThe investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury. The investigators expect lower HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the investigators expect the incidence of arrhythmias, need for prolonged inotropic support (longer than 24 hours postoperative) to be decreased in pretreated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptation for CABG in RUNMC\n* Informed consent\n\nExclusion Criteria:\n\n* Recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion\n* Asthma\n* Use of insulin\n* Use of sulfonylurea derivates (e.g. glibenclamide, tolbutamide, gliclazide, glimepiride)\n* Use of metformin\n* Use of oral corticosteroids\n* Use of dipyridamole\n* Use of clopidogrel within 8 days prior to scheduled CABG surgery\n* Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAIDs)\n* Off-pump surgery'}, 'identificationModule': {'nctId': 'NCT01295567', 'briefTitle': 'Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG)?', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective CABG?', 'orgStudyIdInfo': {'id': 'dipy-cabg'}, 'secondaryIdInfos': [{'id': '2009-014299-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'dipyridamole', 'interventionNames': ['Drug: Dipyridamole']}], 'interventions': [{'name': 'Dipyridamole', 'type': 'DRUG', 'otherNames': ['persantin'], 'description': 'prior to CABG surgery 3 day treatment with dipyridamole 200mg SR twice daily', 'armGroupLabels': ['dipyridamole']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'prior to CABG surgery 3 day treatment with placebo capsules twice daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'RUNMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'G. Rongen', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}