Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT00812032
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2008-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2008-12-18', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)', 'timeFrame': '12 or 24 hours after last dose of Aspirin'}], 'secondaryOutcomes': [{'measure': 'Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.', 'timeFrame': '12 or 24 hours after last dose of aspirin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NIDDM', 'Aspirin', 'platelet inhibition', 'Aspirin treatment'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 DM with micro- or macroangiopathy.\n* HbA1c 6-9 % (Mono-S method).\n* Need for, or already on-going aspirin treatment.\n* Age 50-75 years\n* Antecubital forearm veins allowing technically good sampling for platelet studies\n\nExclusion Criteria:\n\n* Diet controlled DM.\n* Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.\n* Acute or chronic kidney disease (P-cystatin C within the reference interval)\n* Acute or chronic liver disease (ALAT ≤2 times the upper reference value).\n* A history of gastric or duodenal ulcer disease.\n* Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.\n* Thrombocytopenia (platelet count \\<150 x 109/L)\n* Anticipated need for alteration of concomitant drug therapy during the course of the study.\n* Enrollment in another clinical study.\n* Contraindication(s) to aspirin treatment."}, 'identificationModule': {'nctId': 'NCT00812032', 'acronym': 'DM-ASA 001', 'briefTitle': 'Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'EudraCT No: 2007-003186-40'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Trombyl'], 'description': '75 mg per day versus 75 mg twice daily and 320mg once daily'}, {'name': 'aspirin', 'type': 'DRUG', 'otherNames': ['Trombyl'], 'description': 'crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Paul Hjemdahl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paul Hjemdahl', 'investigatorAffiliation': 'Karolinska Institutet'}}}}