NCT05825391

Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 590 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DRUG	Adjustment of Antiplatelet Drugs	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.

Timeline

• Start date: 2023-05-04
• Primary completion: 2023-10-03
• Completion: 2023-10-29
• First posted: 2023-04-24
• Last updated: 2023-11-18

Locations

2 sites across 1 country: China