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Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling (ATIASC)

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ClinicalTrials.gov Identifier: NCT02224131
Recruitment Status : Not yet recruiting
First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Youxiang Li, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date August 25, 2014
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
ischemia stroke [ Time Frame: within 6 months after the stent placement ]
Evidence of clinically definite ischemic stroke confirmed by MRI
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
bleeding [ Time Frame: within 6 months after stent placement ]
Evidence of clinically definite bleeding complication confirmed by CT or clinical symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling
Official Title  ICMJE Randomized Comparison of Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus a Common Antiplatelet Treatment for Intracranial Aneurysm Stent-assisted Coiling
Brief Summary Patients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes of intracranial aneurysm patients undergoing stent deployment by individualizing therapy.This trial is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose adjustment in suboptimal responders as compared to a more conventional strategy without monitoring and without dose adjustment to reduce the primary end point evaluated 6 months after stent deployment in patients with intracranial aneurysms.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Embolic Stroke
Intervention  ICMJE
  • Drug: Aspirin and clopidogrel
    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 Enteric Coated Tablets ,Bayer HealthCare AG ;
    • Plavix
  • Drug: Aspirin and clopidogrel
    aspirin and clopidogrel maintenance doses (according to international guidelines)
    Other Names:
    • Aspirin Enteric Coated Tablets
    • Plavix
Study Arms  ICMJE
  • Experimental: Monitoring Arm
    dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay(TEG)
    Interventions:
    • Drug: Aspirin and clopidogrel
    • Drug: Aspirin and clopidogrel
  • Active Comparator: Conventional Arm
    fixed dose regiment of both aspirin and clopidogrel in all patients following stent deployment according to international guidelines
    Interventions:
    • Drug: Aspirin and clopidogrel
    • Drug: Aspirin and clopidogrel
Publications * Collet JP, Cuisset T, Rangé G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrié D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monségu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthélémy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2014)
1856
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongchao Yang, Doctor +86010-67098847 yhchao2007@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224131
Other Study ID Numbers  ICMJE BT-1401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Youxiang Li, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Youxiang Li, Professor Department of neurointervention of Beijing Neurosurgical Institute,capital medical university ,China
PRS Account Beijing Tiantan Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP