Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT02607358
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 496}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder status', 'timeFrame': 'immediately', 'description': 'Platelet reactivity with PRU measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clopidogrel', 'acetacylic acid', 'antiplatelet therapy', 'HOTPR', 'VerifyNow'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients.', 'detailedDescription': 'Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute Ischemic stroke patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid\n\nExclusion Criteria:\n\n* Previous treatment with platelet inhibitor\n* NOAC or Vitamin K-antagonist treatment\n* Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack'}, 'identificationModule': {'nctId': 'NCT02607358', 'acronym': 'NATIS', 'briefTitle': 'Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'NATIS: Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke', 'orgStudyIdInfo': {'id': 'SJ-390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clopidogrel', 'description': 'Clopidogrel non-responders (HOTPR) Blood sampling for HOTPR-testing', 'interventionNames': ['Other: blood sampling for HOTPR-testing']}, {'label': 'Acetacylicacid', 'description': 'Acetcylicacid non-responders (HOTPR), Blood sampling for HOTPR-testing', 'interventionNames': ['Other: blood sampling for HOTPR-testing']}], 'interventions': [{'name': 'blood sampling for HOTPR-testing', 'type': 'OTHER', 'description': 'All subjects are tested for responderstatus using the VerifyNow System', 'armGroupLabels': ['Acetacylicacid', 'Clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Neurologisk afdeling', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Charlotte Rath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zealand University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}