Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 3:10 PM
Study NCT ID:
NCT01314235
Status:
UNKNOWN
Last Update Posted:
2011-03-14
First Post:
2011-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2011-03-11', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of participants with an activated area under the curve in ASPI test', 'timeFrame': '30 minutes', 'description': 'Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in ASPI test, i.e. an activated area under the curve in Multiplate analysis.'}], 'secondaryOutcomes': [{'measure': 'Numbers of participants with an activated area under the curve in TRAP test and ADP test', 'timeFrame': '30 minutes', 'description': 'Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in TRAP test and ADP test, i.e. an activated area under the curve in Multiplate analysis.'}]}, 'conditionsModule': {'keywords': ['anticoagulation with ASS', 'anticoagulation with clopidogrel'], 'conditions': ['Anticoagulation']}, 'descriptionModule': {'briefSummary': 'Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD.\n\nThe investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients going under vascular surgery with anticagulation with both ASS and clopidogrel', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel\n* Age above 18 years\n\nExclusion Criteria:\n\n* Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation\n* Surgery within the last two weeks\n* Patients with long-term mediaction with omeprazole\n* Patients under hemodialysis\n* Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl)\n* Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I)\n* Age under 18 yeary\n* Non-responder to ASS and / or clopidogrel'}, 'identificationModule': {'nctId': 'NCT01314235', 'briefTitle': 'Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study', 'orgStudyIdInfo': {'id': 'Clonidinstudy'}}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Schmidt, M.D.', 'role': 'CONTACT', 'email': 'philipp.schmidt@kgu.de'}], 'facility': 'Johann-Wolfgang-Goethe University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Philipp Schmidt', 'oldOrganization': 'Goethe University'}}}}