NCT03989557

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Beijing Neurosurgical Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Unruptured Intracranial Aneurysm
• Stents
• Antiplatelet Drugs

Interventions

Type	Name	Description
DRUG	Aspirin and clopidogrel/Ticagrelor	The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
DEVICE	Light transmittance aggregometry	point-of-care method to assess platelet function by light transmittance aggregometry.
DRUG	Aspirin and clopidogrel/Ticagrelor	maintenance dose of aspirin, clopidogrel and ticagrelor.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-07-20
• Completion: 2020-08-13
• First posted: 2019-06-18
• Last updated: 2020-09-09

Locations

1 site across 1 country: China