CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 590 enrolled
Drug / intervention
Adjustment of Antiplatelet Drugsdrug
Likely dose
Adjustment of Antiplatelet Drugs 200mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05825391
NCT05825391N/ACompleted

Guided Versus Standard Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study

Beijing Tiantan Hospital·interventional·Posted Apr 24, 2023·Updated Nov 18, 2023

In Brief

A clinical study evaluating Adjustment of Antiplatelet Drugs for Intracranial Aneurysm. Completed, enrolled 590 participants across 2 sites.

Detailed Summary

The use of intracranial stents expands the possibilities for endovascular treatment of intracranial aneurysms and improves the success rate. However, it also increases the risk of ischemic complications in patients. The current standard dual antiplatelet regimen is considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In clinical practice, there is a lack of standardized platelet function testing and consensus on adjusting antiplatelet drug programs. This study conducted a multi-center, prospective cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of ischemic events after stent implantation in patients with unruptured intracranial aneurysms. Additionally, the study aimed to establish a set of standardized antiplatelet regimens.

Study Details

Timeline

N/ACompletedFinished
202420252026
First PostedApr 24, 2023
Enrollment StartMay 4, 2023
Primary CompletionOct 3, 2023
Study CompletionOct 29, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.2 years ago

Interventions

Adjustment of Antiplatelet Drugsdrug

The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization,give ticagrelor 60mg bid. ADP-MPA\<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid.