Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

Study Overview
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Brief Summary
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Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

Detailed Description
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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.

Official Title
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Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling of Unruptured Intracranial Aneurysms: A Prospective Randomized Multicenter Trial

Conditions
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Aneurysm Cerebral, Endovascular Procedures

Intervention / Treatment
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* Drug: Aspirin 100mg
* Drug: Clopidogrel 75mg


Participation Criteria
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Eligibility Criteria
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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] aspirin reaction unit (ARU) < 550 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: short-term dual antiplatelet group: for 6 months long-term dual antiplatelet group: for 12 months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: short-term dual antiplatelet group<br>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 | Drug: Aspirin 100mg<br>* short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months<br>* Other names: Aspirin enteric coated;Drug: Clopidogrel 75mg<br>* short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months<br>* Other names: Jgrel;|
| Experimental: long-term dual antiplatelet group<br>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. | Drug: Aspirin 100mg<br>* short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months<br>* Other names: Aspirin enteric coated;Drug: Clopidogrel 75mg<br>* short-term dual antiplatelet: dual antiplatelet agents for 6 months long-term dual antiplatelet: dual antiplatelet agents for 12 months<br>* Other names: Jgrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic complications | The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure. | between 1 and 18 months after stent-assisted coil embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of periprocedural complications | Incidence of periprocedural complications during procedure and within 1 month post-procedure | during procedure and within 1 month post-procedure | 
| Incidence of hemorrhagic complications | Incidence of hemorrhagic complications between 1 and 18 months post-procedure. | between 1 and 18 months after stent-assisted coil embolization | 
| Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up | Changes in clinical and functional outcomes at 18 months follow up, as measured by an increase in the modified Rankin Scale compared to baseline (modified Rankin Scale: 0) no symptoms, 1) able to carry out all usual activities, despite some symptoms, 2) able to look after own affairs without assistance, but unable to carry out all previous activities, 3) requires some help, but able to wal unassisted, 4) unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5) requires constant nursing care and attention, bedridden, incontinent and 6) dead. | within 18 months post-procedure | 
| Incidence of unrelated complication with this study | Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study | within 18 months post-procedure | 
| Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow | Change in aspirin reaction unit and P2Y12 reaction unit at the time of 6 months follow-up compared to baseline by using VerifyNow (Accumetrics, USA) | at 6 months | 
| Periprocedural mortality | Death within 1 month | within 1 month | 
| Comparison of mortality | Death between 1 and 18 months post-procedure | between 1 and 18 months after stent-assisted coil embolization | 
| Changes in radiological outcomes by Roy-Raymond grades | Change in radiological outcomes at 18 months follow up compared to baseline as measured by Roy-Raymond grades: 1) complete, 2) residual neck, and 3) residual sac | at 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual antiplatelet, cerebral aneurysm, coil embolization, stent