- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02224131
Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling (ATIASC)
Randomized Comparison of Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus a Common Antiplatelet Treatment for Intracranial Aneurysm Stent-assisted Coiling
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participating Centers : 10 China high neurointervention volume (>200) centers Rationale: Clopidogrel (75 mg/day), in combination with aspirin (100 mg/day), is currently the antiplatelet treatment of choice for prevention of stent thrombosis, and clinical trials have shown that, in high-risk patients, prolonged dual antiplatelet treatment is more effective than aspirin alone in preventing major thromboembolic events. However, despite the use of clopidogrel, a considerable number of patients continue to have thromboembolic events. Numerous in VITRO studies have shown that individual responsiveness to clopidogrel but also to aspirin is not uniform in all patients and is subject to inter- and intraindividual variability. The recent possibility of bedside monitoring of oral antiplatelet therapy offers the unique opportunity of tailoring antiplatelet therapy. However, the relevance of such strategy has never been evaluated in a randomized prospective adequately powered study of intracranial aneurysm patients. Late state stent thrombosis and after interruption of OAT, is another important safety issue raising the questions of the modalities of interruption of dual OAT within six months according to the most recent updated recommendations. When is the best interruption of dual OAT? Our first hypothesis is that a strategy of dose adjustment of OAT based on biological monitoring reduces the rate of the combined ischemic endpoints of death, stent thrombosis and stroke as compared to a conventional strategy (local practice without monitoring) in patients scheduled for intracranial stent implantation and followed up for six months. Our second hypothesis is that interruption of clopidogrel after 1.5 months of dual OAT is associated with a higher rate of the same combined ischemic endpoints as compared with patients in whom dual OAT is maintained for 3 months follow-up.
Objectives: 1) To demonstrate the superiority of the strategy of monitoring with dose adjustment in suboptimal responders (Monitoring Arm) as compared to a more conventional strategy (Conventional Arm) with fixed dose regimen of both oral antiplatelet agents in all patients as defined by the international guidelines to reduce the primary endpoint evaluated one year after DES implantation. 2) to demonstrate the superiority of a strategy of pursuit of a dual OAT beyond 3 months(Pursuit Arm) as compared to a strategy of interruption for 1.5 months(Interruption Arm).
Duration of the participation : from 18 up to 30 months according to the time delay from study start to randomization. No participants will be excluded from the study at the exception of consent withdrawal. However, participants who have not been randomized for interruption or continuation of DAPT at the 6 month follow up visit will terminate the study
Number of patients: 1856 patients. This number was obtained for the demonstration of the superiority of the strategy of monitoring (Monitoring Arm) over the conventional strategy (Conventional Arm) to reduce the primary endpoint by 33% (relative risk reduction).
Expected results: The ARCTIC study will provide answers to two major clinical challenges. It will also give a unique opportunity to assess the prevalence and the associated risk factors of suboptimal answers to OAT, but also to improve a suboptimal biological response. Finally, the economic impact of both strategies of monitoring and of interruption will be evaluated.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100050
- Beijing Tiantan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients (≥18 years) in whom elective intracranial stent placement is scheduled after diagnostic angiography
- Patients not treated by GPIIb/IIIa inhibitors prior to randomization.
- Provided written consent for participation in the trial prior to any study-specific procedures or requirements
Exclusion Criteria:
•Oral anticoagulation (Vitamin K Antagonists).
- Contraindication for aspirin and/or clopidogrel or GPIIb/IIIa inhibitors or to increasing dose of clopidogrel or aspirin
- Ongoing or recent bleeding and/or recent major surgery (<3 weeks)
- Severe liver dysfunction
- Thrombocytopenia (Platelet count <80000/µl).
- IIb/IIIa inhibitors within a week prior to randomization
- multiple intracranial aneurysms
- Patient at risk of poor compliance to the study
- Patient not affiliated to social security
- Pregnant women, no signed inform consent
- Any invasive or surgical planned intervention during the year after stent placement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monitoring Arm
dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay(TEG)
|
modification of aspirin and clopidogrelmaintenance doses based on a biological assay Device:thrombelastography(TEG) point of care assay TEG(Haemoscope Corporation, Niles, IL)
Other Names:
aspirin and clopidogrel maintenance doses (according to international guidelines)
Other Names:
|
Active Comparator: Conventional Arm
fixed dose regiment of both aspirin and clopidogrel in all patients following stent deployment according to international guidelines
|
modification of aspirin and clopidogrelmaintenance doses based on a biological assay Device:thrombelastography(TEG) point of care assay TEG(Haemoscope Corporation, Niles, IL)
Other Names:
aspirin and clopidogrel maintenance doses (according to international guidelines)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ischemia stroke
Time Frame: within 6 months after the stent placement
|
Evidence of clinically definite ischemic stroke confirmed by MRI
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within 6 months after the stent placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding
Time Frame: within 6 months after stent placement
|
Evidence of clinically definite bleeding complication confirmed by CT or clinical symptoms
|
within 6 months after stent placement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence of aneurysm, all causes of death
Time Frame: within 6 months after stent placement
|
Evidence of clinically definite recurrence of aneurysm confirmed by DSA
|
within 6 months after stent placement
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Youxiang Li, Professor, Department of neurointervention of Beijing Neurosurgical Institute,capital medical university ,China
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Intracranial Arterial Diseases
- Ischemic Stroke
- Aneurysm
- Intracranial Aneurysm
- Embolic Stroke
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Clopidogrel
Other Study ID Numbers
- BT-1401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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