Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Aneurysm Cerebral; Endovascular Procedures

Treatments: Drug: Clopidogrel 75mg; Drug: Aspirin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05257824

B-2102-667-002

Details and patient eligibility

About

Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

Full description

The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.

Enrollment: 528 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects over 19 years old

• subjects with modified Rankin Scale (mRS) ≤ 2

• subjects with unruptured intracranial aneurysms

• subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure [measured using VerifyNow]

  1. aspirin reaction unit (ARU) < 550
  2. P2Y12 reaction unit (PRU): 85~219

• subjects who agreed to this study (with informed consent)

Exclusion criteria

• subjects with neurological deficits (mRS ≥ 3)
• subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
• subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
• subjects with coagulopathy
• subjects with thrombocytopenia (<100,000/mm3)
• subjects with liver diseases (> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
• subjects with renal diseases (> 2mg/dL of serum creatinine)
• subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
• subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
• subjects with uncontrolled congestive heart failure or angina
• subjects with malignant tumors
• subjects with a positive pregnancy test (serum or urine)
• subjects who are unconscious at the time of diagnosis.
• subjects who are unable to complete the required follow-ups
• subjects with life-threatening diseases
• subjects with medical conditions with a life expectancy of less than two years
• subjects 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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528 participants in 2 patient groups

short-term dual antiplatelet group

Active Comparator group

Description:

Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU \< 550 and PRU 85 \~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling

Treatment:

Drug: Aspirin 100mg

Drug: Clopidogrel 75mg

long-term dual antiplatelet group

Experimental group

Description:

Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU \< 550 and PRU 85 \~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.

Treatment:

Drug: Aspirin 100mg

Drug: Clopidogrel 75mg