Aneurysm Cerebral, Endovascular Procedures
Conditions
Keywords
dual antiplatelet, cerebral aneurysm, coil embolization, stent
Brief summary
Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms
Detailed 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.
Interventions
DRUGAspirin 100mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
DRUGClopidogrel 75mg
1. short-term dual antiplatelet: dual antiplatelet agents for 6 months 2. long-term dual antiplatelet: dual antiplatelet agents for 12 months
Sponsors
Pusan National University Yangsan Hospital
Keimyung University Dongsan Medical Center
Uijeongbu St. Mary's Hospital
Chungnam National University Sejong Hospital
Soonchunhyang University Hospital
Asan Medical Center
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. short-term dual antiplatelet group: for 6 months 2. long-term dual antiplatelet group: for 12 months
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of thromboembolic complications | between 1 and 18 months after stent-assisted coil embolization | The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hemorrhagic complications | between 1 and 18 months after stent-assisted coil embolization | Incidence of hemorrhagic complications between 1 and 18 months post-procedure. |
| Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up | within 18 months post-procedure | 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. |
| Incidence of unrelated complication with this study | within 18 months post-procedure | Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study |
| Incidence of periprocedural complications | during procedure and within 1 month post-procedure | Incidence of periprocedural complications during procedure and within 1 month post-procedure |
| Periprocedural mortality | within 1 month | Death within 1 month |
| Comparison of mortality | between 1 and 18 months after stent-assisted coil embolization | Death between 1 and 18 months post-procedure |
| Changes in radiological outcomes by Roy-Raymond grades | at 18 months | 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 |
| Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow | at 6 months | 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) |
Countries
South Korea
Outcome results
None listed