Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT00536068
Status:
COMPLETED
Last Update Posted:
2007-09-28
First Post:
2007-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Inhibition by Aspirin, Acetaminophen and NSAID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'D009288', 'term': 'Naproxen'}], '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'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-27', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'platelet aggregation', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['platelet', 'aggregation', 'aspirin'], 'conditions': ['Hemostasis']}, 'descriptionModule': {'briefSummary': 'Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.', 'detailedDescription': 'An in vivo study on healthy volunteers with combinations of well established drugs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Administration of drugs affecting platelets\n* History of bleeding\n* Gastrointestinal disorders\n* Hypersensitivity to aspirin and/or NSAID\n* Pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT00536068', 'briefTitle': 'Platelet Inhibition by Aspirin, Acetaminophen and NSAID', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Graubünden'}, 'orgStudyIdInfo': {'id': 'KGWR0206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1, 2, 3, 4', 'description': '1. acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po\n2. acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po\n3. acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po\n4. acetylsalicylic acid 100 mg/po,placebo 3x1/po', 'interventionNames': ['Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo']}], 'interventions': [{'name': 'Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo', 'type': 'DRUG', 'description': '1. Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days\n2. Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days\n3. Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days\n4. Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days', 'armGroupLabels': ['1, 2, 3, 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH 7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Kantonsspital Graubünden, Department of Internal Medicine', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}], 'overallOfficials': [{'name': 'Walter H Reinhart, MD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Graubünden', 'class': 'OTHER'}}}}