Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT03471169
Status:
UNKNOWN
Last Update Posted:
2018-03-20
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Platelet aggregability', 'timeFrame': 'one year', 'description': 'The value of maximum extent of thrombosis around 31-47 mm'}], 'primaryOutcomes': [{'measure': 'Efficient Aspirin', 'timeFrame': 'one year', 'description': 'The value of inhibition rate of Aspirin \\> 50%'}], 'secondaryOutcomes': [{'measure': 'Efficient Clopidogrel', 'timeFrame': 'one year', 'description': 'The value of adenosine diphosphate\\> 30%'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antithrombotic therapy'], 'conditions': ['Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.', 'detailedDescription': 'Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14 years of age or older\n* no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients\n* The researcher (or principal) signs the informed consent form\n\nExclusion Criteria:\n\n* Significant head trauma or stroke in the last 3 months\n* 3 months to accept intracranial, spinal surgery or other parts of large surgery\n* In the last week there is an incurable part of the artery puncture\n* Acute bleeding constitution, including platelet count \\<100 × 109 / L or other conditions\n* within the last 48h heparin treatment, APTT higher than the upper limit of normal range\n* Oral anticoagulant: INR\\> 1.7 or PT\\> 15s\n* The presence of intracranial tumors, aneurysms or arteriovenous malformations\n* Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator)\n* Severe liver and kidney dysfunction\n* Life expectancy is less than 1 year\n* Pregnant or lactating women\n* Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research\n* Allergic or intolerant to aspirin or clopidogrel\n* There are stomach lesions, such as gastritis, gastric ulcer and so on\n* Do not want to follow-up or poor treatment compliance'}, 'identificationModule': {'nctId': 'NCT03471169', 'briefTitle': 'Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing', 'orgStudyIdInfo': {'id': 'jinqiaowml'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desirable TEG', 'description': 'Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.', 'interventionNames': ['Drug: Desirable TEG']}, {'type': 'SHAM_COMPARATOR', 'label': 'Undesirable TEG', 'description': 'Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.', 'interventionNames': ['Drug: Undesirable TEG']}], 'interventions': [{'name': 'Desirable TEG', 'type': 'DRUG', 'otherNames': ['blood sampling'], 'description': 'Change the type and dose of antithrombotic therapy and obtain desirable TEG results.\n\nAntithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.', 'armGroupLabels': ['Desirable TEG']}, {'name': 'Undesirable TEG', 'type': 'DRUG', 'otherNames': ['blood sampling'], 'description': "Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.", 'armGroupLabels': ['Undesirable TEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Xicheng', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qian Zhang', 'role': 'CONTACT', 'email': 'zhangqian_zq630@sina.com', 'phone': '13911256080'}], 'facility': 'XuanWu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Moli Wang, 1', 'role': 'CONTACT', 'email': 'yifanhahahah@163.com', 'phone': '13801234991'}, {'name': 'Qian Zhang, 2', 'role': 'CONTACT', 'email': 'zhangqian_zq@630.sina.com', 'phone': '13911256080'}], 'overallOfficials': [{'name': 'Qian Zhang, 1', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}