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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Jiangnan University Central Hospital | UNKNOWN |
| Beijing Chao Yang Hospital |
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This project aims to evaluate the safety and efficacy of the antiplatelet regimen combining indobufen and clopidogrel in preventing ischemic events after stent-assisted coiling embolization and flow diverter implantation for intracranial aneurysms.
Using a randomization system, patients with unruptured intracranial aneurysms scheduled for interventional treatment will be divided into an experimental group and a control group. Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively.
An independent group of researchers will assess cerebrovascular thromboembolic events and bleeding events at different time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indobufen+clopidogrel group | Experimental | Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. |
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| Aspirin+clopidogrel group | Active Comparator | Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indobufen treatment | Drug | Patients in the experimental group will be required to take indobufen (100 mg twice daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint Events: Cerebrovascular thromboembolic events occurring within 90 days postoperatively | Cerebrovascular thromboembolic events within 90 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death | within 90 days after endovascular treatment of unruptured intracranial aneurysms |
| Primary Safety Endpoint Events: Incidence of bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms. | Bleeding events classified as Type 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) criteria within 90 days after endovascular treatment of unruptured intracranial aneurysms. | Within 90 days after endovascular treatment of unruptured intracranial aneurysms. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrovascular thromboembolic events occurring within 30 days postoperatively | Cerebrovascular thromboembolic events within 30 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death | Within 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyuan Liu, M.D. | Contact | +86-13260457220 | 13260457220@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Shuyi Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
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| Aspirin treatment | Drug | Patients in the control group will be required to take aspirin (100 mg once daily) + clopidogrel (75 mg once daily) starting 5 days before the procedure and continuing until 180 days postoperatively. |
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| Cerebrovascular thromboembolic events occurring within 180 days postoperatively | Cerebrovascular thromboembolic events within 180 days after endovascular treatment of unruptured intracranial aneurysms, including: Ischemic stroke, Transient ischemic attack (TIA), Stent thrombosis, Emergency revascularization, Cerebrovascular death | Within 180 days postoperatively |
| Platelet aggregation rate within 24 hours before surgery | Platelet aggregation rate within 24 hours before surgery, including ADP-induced platelet aggregation, Collagen-induced platelet aggregation and Arachidonic acid-induced platelet aggregation. | Within 24 hours before surgery |