Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT03989557
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2019-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], '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': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2019-06-16', 'studyFirstSubmitQcDate': '2019-06-16', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Major bleeding and minor bleeding', 'timeFrame': "within 1 month of patients' enrolled.", 'description': 'Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.'}], 'primaryOutcomes': [{'measure': 'A thromboembolic event during the early periprocedural period (within 7 days after stent placement)', 'timeFrame': "within 7 days of patients' enrolled.", 'description': 'The thromboembolic events were assessed by clinical examination. The thromboembolic events was a composite of ischemic stroke, transient ischemic attack, stent thrombosis, urgent revascularization, myocardial infarction, cerebrovascular death.'}], 'secondaryOutcomes': [{'measure': 'A thromboembolic event during the 1 month follow-up periods.', 'timeFrame': "within 1 month of patients' enrolled."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet function test', 'high platelet reactivity', 'light transmittance platelet aggregometry'], 'conditions': ['Unruptured Intracranial Aneurysm', 'Stents', 'Antiplatelet Drugs']}, 'referencesModule': {'references': [{'pmid': '34538087', 'type': 'DERIVED', 'citation': 'Li W, Zhu W, Wang A, Zhang G, Zhang Y, Wang K, Zhang Y, Wang C, Zhang L, Zhao H, Wang P, Chen K, Liu J, Yang X. Effect of Adjusted Antiplatelet Therapy on Preventing Ischemic Events After Stenting for Intracranial Aneurysms. Stroke. 2021 Dec;52(12):3815-3825. doi: 10.1161/STROKEAHA.120.032989. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to identify high platelet reactivity (HPR) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (LTA). For HPR patients, higher ischemic stroke rate maybe occurred, and we hypothesis that dose adjustment of aspirin and clopidogrel based on LTA monitoring maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial stent implantation at early periprocedural period and 1 month follow-up period.', 'detailedDescription': 'For the patients of unruptured intracranial aneurysms with stent placement, standard antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most effective antiplatelet regimen in reducing ischemic complications. However, despite the use of standard antiplatelet therapy, a number of patients continue to have ischemic events. A hypothesis is that high platelet reactivity (HPR) patients identified by platelet function test have higher ratio of the ischemic events, and dose adjustment of HPR patients reduces the rate of the ischemic complications at early periprocedural period and follow-up period.\n\nObjectives: The study aim to evaluated the superiority of the strategy of platelet function test(Monitoring Arm) with the modified strategy in HPR patients compared to the standard strategy (Conventional Arm) whether reduce the primary endpoint after intracranial stent implantation at early periprocedural period (7 days) and 1 months follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 - 80, male or non-pregnant female;\n2. patients have unruptured aneurysm who plan to undergo intracranial stent placement;\n3. patients with less than 2 of modified Rankin scale score at the day of enrollment;\n4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.\n\nExclusion Criteria:\n\n1. The complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc;\n2. Simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, Intracranial arteriovenous fistula, etc;\n3. Patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor;\n4. Patients with preoperative prophylactic use of tirofiban;\n5. Patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy;\n6. Patients with thrombocytopenia (platelet count \\<100,000/mm3 within three months before enrollment);\n7. patient using anticoagulant;\n8. Pregnant or lactating women;\n9. Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;\n10. Poor compliance patients.'}, 'identificationModule': {'nctId': 'NCT03989557', 'acronym': 'APISIA Trail', 'briefTitle': 'Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Neurosurgical Institute'}, 'officialTitle': 'A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms', 'orgStudyIdInfo': {'id': 'BNI-2019002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monitoring Arm', 'description': 'Randomization: based on light transmittance aggregometry, modified dose of antiplatelet therapy(aspirin and ticagrelor) was used for high platelet reactivity(HPR) patients with intracranial stent placement, and standard antiplatelet regimen(aspirin and clopidogrel) was used in non-HPR patients.', 'interventionNames': ['Drug: Aspirin and clopidogrel/Ticagrelor', 'Device: Light transmittance aggregometry']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional Arm', 'description': 'Randomization: without light transmittance aggregometry, standard antiplatelet regimen was used for unruptured aneurysm patients with intracranial stent.', 'interventionNames': ['Drug: Aspirin and clopidogrel/Ticagrelor']}], 'interventions': [{'name': 'Aspirin and clopidogrel/Ticagrelor', 'type': 'DRUG', 'description': 'The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.', 'armGroupLabels': ['Monitoring Arm']}, {'name': 'Light transmittance aggregometry', 'type': 'DEVICE', 'description': 'point-of-care method to assess platelet function by light transmittance aggregometry.', 'armGroupLabels': ['Monitoring Arm']}, {'name': 'Aspirin and clopidogrel/Ticagrelor', 'type': 'DRUG', 'description': 'maintenance dose of aspirin, clopidogrel and ticagrelor.', 'armGroupLabels': ['Conventional Arm', 'Monitoring Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Neurosurgical Institute and Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Neurosurgical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}