Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Aneurysm, Cerebral; Endovascular Procedures

Treatments: Drug: Prasugrel; Drug: Aspirin; Drug: Cilostazol; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT03581409

B-1712/439-001

Details and patient eligibility

About

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

Full description

Comparison between dual-antiplatelet and triple-platelet preparation

Enrollment: 198 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

dual-antiplatelet

Experimental group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Prasugrel

triple-antiplatelet

Experimental group

Description:

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.

Treatment:

Drug: Clopidogrel

Drug: Cilostazol

Drug: Aspirin