Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT00262561
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2005-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-25', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intermittent Claudication', 'Aspirin resistance', 'Clopidogrel resistance'], 'conditions': ['Intermittent Claudication']}, 'descriptionModule': {'briefSummary': '263 patients with peripheral atherosclerosis were examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg of clopidogrel 2 h before platelet reactivity analysis.\n\nThe main hypothesis is that high platelet activity at the beginning of the study is associated with a higher risk of atherothrombosis. Follow up time is 5 years.', 'detailedDescription': "Patients with peripheral atherosclerosis are at high risk of atherothrombosis, mainly heart attack and stroke. The medical treatment of these patients include platelet inhibiting drugs, usually aspirin, to reduce the risk of ischemic events. Clopidogrel is another platelet inhibiting drug, which is prescribed less often, primarily because of the high costs compared to aspirin.\n\nPhenomena of 'resistance' to these drugs have been described by numerous investigators. Essentially resistance means that the effect of the drug described is less than expected or missing, as measured by various laboratory methods. We do not know which way resistance is best described, but it has been described that patients who are 'resistant' to either drug are less protected against future heart attacks or strokes.\n\nMain objectives:\n\n* To measure the activity of platelets in these patients during aspirin treatment.\n* To measure the activity of platelets in a minor population of these patients during clopidogrel treatment.\n* To evaluate the prognostic significance of resistance to aspirin in these patients.\n\nMethods:\n\nPlatelet activity is measured by the PFA-100 (Dade Behring) and by traditional turbidimetric aggregation.\n\nEndpoints:\n\nMyocardial infarction, unstable angina, cerebral infarction, transitory cerebral ischaemia, sudden deterioration of symptoms, percutaneous or surgical vascular intervention, amputation, death."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Atherosclerosis of the lower limbs, defined by one of the following criteria: Ankle-Brachial Pressure Index (ABPI)\\< 0.9, intermittent claudication, ischaemic pain at rest, ischaemic ulcers or gangrene.\n* Age \\> 18 years\n* For fertile women: Use of safe contraception (intrauterine contraceptive device, the pill, hormonal skin patches, progestogen injections, progestogen implant, vaginal ring)\n\nExclusion Criteria:\n\n* Allergy to either Aspirin or Clopidogrel\n* Known bleeding disorder\n* Platelet count \\< 140 mia/L or \\> 400 mia/L\n* Intake of NSAID's, SSRI's or Dipyridamol within the preceding 14 days\n* Not radically treated gastrointestinal ulceration within the last 6 month\n* Greater surgical procedures performed within the last 3 month\n* Severe renal disease\n* Severe hepatic disease\n* Breast feeding\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00262561', 'briefTitle': 'Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Prevalence of Resistance to Aspirin and/or Clopidogrel Among Patients With PAD. Prognostic Significance of Resistance to Aspirin', 'orgStudyIdInfo': {'id': '2005-003844-68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin', 'description': 'All participants get Aspirin, and platelet reactivity measurements are performed.', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': 'The effect of Aspirin on platelet function was assessed.', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Vascular Surgery, Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Nils Johannesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Vascular Surgery, Aalborg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Esben Hjorth Madsen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}