Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
NCT Number: NCT03989557
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100050, China
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.
Objectives: 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
point-of-care method to assess platelet function by light transmittance aggregometry.
Time frame: within 7 days of patients' enrolled.
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.
Time frame: within 1 month of patients' enrolled.
Time frame: within 1 month of patients' enrolled.
Bleeding complications were accorded to Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria.
Beijing Neurosurgical Institute
Other
A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Acronym: APISIA Trail
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