Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Phase 4

Completed

• Conditions: Aneurysm, Cerebral; Endovascular Procedures
• Interventions: Drug: Aspirin; Drug: Prasugrel; Drug: Clopidogrel; Drug: Cilostazol

• Registration Number: NCT03581409
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm

Detailed Description

Comparison between dual-antiplatelet and triple-platelet preparation

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-07-08
• Study First Posted: 2018-07-10
• Study Start: 2018-10-24
• Status Verified: 2019-10
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-22
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• patients with clopidogrel resistance (greater than 220 P2Y12 reaction units using VerifyNow)
• patients with unruptured intracranial aneurysms
• patients over 20 years old
• patients who can communicate with each other
• patients who agreed to this study (with informed consent)

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Exclusion Criteria

• patients with recurrent aneurysms after coiling or clipping
• patients with allergic reaction to antiplatelets
• patients with high risks of hemorrhage
• patients with coagulopathy
• patients with thrombocytopenia (<100,000/mm3)
• patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
• patients with renal disease (> 2mg/dL of serum creatinine)
• patients with uncontrolled heart failure or angina
• patients with malignant tumor
• pregnant patients
• patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
• Patients who are determined to be disqualified by researchers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dual-antiplatelet	Aspirin	Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg \& prasugrel 5mg) treatment continued for 3 months through study completion.
dual-antiplatelet	Prasugrel	Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg \& prasugrel 5mg) treatment continued for 3 months through study completion.
triple-antiplatelet	Clopidogrel	Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
triple-antiplatelet	Cilostazol	Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.
triple-antiplatelet	Aspirin	Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion.

Primary Outcome Measures

Name	Time	Method
Incidence of hemorrhagic complications between 2 arms	through study completion (for 3 months)	check minor and major hemorrhagic complications of intra- and post-procedures

Secondary Outcome Measures

Name	Time	Method
Change of the level of P2Y12	through study completion (for 3 months)	Check the change of the level of P2Y12 according to each arms during study periods
mortality between 2 arms	through study completion (for 3 months)	check mortality after procedures
Incidence of thromboembolic complications between 2 arms	through study completion (for 3 months)	check minor and major thromboembolic complications of intra- and post-procedures

Trial Locations

Locations (1)

Seoul National Univeristy Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of