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Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms — APISIA Trail  

Stents Clinical Trial

Official title:
A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03989557
Study type Interventional
Source Beijing Neurosurgical Institute
Contact
Status Completed
Phase Phase 4
Start date July 1, 2019
Completion date August 13, 2020
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