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Completed

NCT Number: NCT05257824

Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

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

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Key information

Conditions

Aneurysm Cerebral Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Procedures Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chungnam National University Sejong Hospital, Sejong, Chungcheongnam-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 100mg

Drug
  • short-term dual antiplatelet: dual antiplatelet agents for 6 months
  • long-term dual antiplatelet: dual antiplatelet agents for 12 months

Other names: Aspirin protect, Aspirin enteric coated

Clopidogrel 75mg

Drug
  • short-term dual antiplatelet: dual antiplatelet agents for 6 months
  • long-term dual antiplatelet: dual antiplatelet agents for 12 months

Other names: Plavix, Celavix, Plavitor, Pregrel, Cloart, Platless, Pidogle, Antipla, Jgrel

Primary outcomes

  1. Incidence of thromboembolic complications

    Time frame: 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 outcomes

  1. Incidence of periprocedural complications

    Time frame: during procedure and within 1 month post-procedure

    Incidence of periprocedural complications during procedure and within 1 month post-procedure

  2. Incidence of hemorrhagic complications

    Time frame: between 1 and 18 months after stent-assisted coil embolization

    Incidence of hemorrhagic complications between 1 and 18 months post-procedure.

  3. Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up

    Time frame: 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.

  4. Incidence of unrelated complication with this study

    Time frame: within 18 months post-procedure

    Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study

  5. Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow

    Time frame: 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)

  6. Periprocedural mortality

    Time frame: within 1 month

    Death within 1 month

  7. Comparison of mortality

    Time frame: between 1 and 18 months after stent-assisted coil embolization

    Death between 1 and 18 months post-procedure

  8. Changes in radiological outcomes by Roy-Raymond grades

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Asan Medical Center
  • Chungnam National University Sejong Hospital
  • Gangnam Severance Hospital, Yonsei University College of Medicine
  • Keimyung University Dongsan Medical Center
  • Pusan National University Yangsan Hospital
  • Soonchunhyang University Hospital
  • Uijeongbu St. Mary's Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2022
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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