Clinical trial NCT05825391: Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms
Official title: Guided Versus Standard Antiplatelet Therapy in Intracranial Aneurysm Intervention With Stents: a Cluster Randomized Controlled Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysm
Interventional Therapy
Stent
Platelet
Ischemic Stroke
Bleeding Event
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Chinese PLA General Hospital
name: Beijing Chao Yang Hospital
name: Peking University International Hospital
name: Peking University First Hospital
name: Hebei Medical University Third Hospital
name: Tianjin Medical University General Hospital
First posted: 2023-04-24
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled cohort study
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ischemic events
timeFrame: 30 days after stent implantation.
Secondary outcomes:
Other outcomes:
measure: Bleeding events
timeFrame: 30 days after stent implantation.
Locations:
city: Beijing
country: China
facility: Beijing Tiantan hospital
state: Beijing
city: Beijing
country: China
facility: Department of Neurosurgery, Beijing Tiantan Hospital.
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Xinjian Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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