Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms

Not Applicable

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Drug: Adjustment of Antiplatelet Drugs

• Registration Number: NCT05825391
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-04-24
• Study Start: 2023-05-04
• Primary Completion: 2023-10-03
• Study Completion: 2023-10-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

1. Patients with unruptured intracranial aneurysms who received intracranial stenting,
2. Standard dualantiplatelet therapy for at least 5 days before stent implantation,
3. Patients aged 18-80,
4. on the day of registration patients with a Modified Rankin Scale lower than 2,
5. patients who agree and sign the consent form.

Exclusion Criteria

1. Patients with recurrent aneurysms after interventional therapy or clipping therapy,
2. Patients with a history of allergy to aspirin, clopidogrel or ticagrelor,
3. Patients who used tirofiban prophylactically before surgery,
4. Possible active bleeding Patients with high blood pressure, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with bleeding tendency or coagulation dysfunction,
5. Any abnormal platelet count (normal value is 100-300 × 10^9/L),
6. Patients using anticoagulants,
7. Pregnant or lactating women,
8. Suffering from liver disease, kidney disease, congestive heart failure, malignant tumors and other malignant diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Adjustment of Antiplatelet Drugs	Use a guided antiplatelet regimen based on LTA testing

Primary Outcome Measures

Name	Time	Method
Ischemic events	30 days after stent implantation.	ischemic stroke, transient ischemic stroke (TIA), stent thrombosis

Trial Locations

Locations (2)

Department of Neurosurgery, Beijing Tiantan Hospital.; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan hospital; 🇨🇳 Beijing, Beijing, China