drugset / Trial / NCT03989557

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

NCT03989557 ↗

Phase 4 Completed 314 enrolled Beijing Neurosurgical Institute
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-07-01
Primary completion
2020-07-20
Completion
2020-08-13

Outcome

Met primary endpoint

paper The primary combined outcome occurred in 19 patients (12.1%) in the conventional group and 8 patients (5.1%) in the monitoring group (hazard ratio, 0.39 [95% CI, 0.17-0.92]; P=0.03). PMID 34538087 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg —
Subject Clopidogrel Small molecule 75 mg —
Subject Ticagrelor Small molecule — —

Indications