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Trial record 44 of 1261 for:    ASPIRIN AND Platelet Aggregation

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

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.

Condition or disease Intervention/treatment Phase
Embolic Stroke Drug: Aspirin and clopidogrel Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1856 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus a Common Antiplatelet Treatment for Intracranial Aneurysm Stent-assisted Coiling
Study Start Date : January 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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)
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

Active Comparator: Conventional Arm
fixed dose regiment of both aspirin and clopidogrel in all patients following stent deployment according to international guidelines
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




Primary Outcome Measures :
  1. ischemia stroke [ Time Frame: within 6 months after the stent placement ]
    Evidence of clinically definite ischemic stroke confirmed by MRI


Secondary Outcome Measures :
  1. bleeding [ Time Frame: within 6 months after stent placement ]
    Evidence of clinically definite bleeding complication confirmed by CT or clinical symptoms


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224131


Contacts
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Contact: Hongchao Yang, Doctor +86010-67098847 yhchao2007@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Youxiang Li, Doctor    86010_67098847    yhchao2007@163.com   
Principal Investigator: Hongchao Yang, Doctor         
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Chair: Youxiang Li, Professor Department of neurointervention of Beijing Neurosurgical Institute,capital medical university ,China

Publications:
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Responsible Party: Youxiang Li, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02224131     History of Changes
Other Study ID Numbers: BT-1401
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Youxiang Li, Beijing Tiantan Hospital:
platelet function test
stent;

Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents