Study of Antiplatelet Therapy for Intracranial Aneurysm Stent-assisted Coiling

NCT02224131 | Unknown Phase 4 DMC

• 1 other identifier: BT-1401
• Study Type: interventional
• Target: 1,856
• Locations: 1 country
• Sites: 1

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.

Conditions

Embolic Stroke

Keywords

platelet function test; stent;

Outcome Measures

Primary Outcomes (1)

• ischemia stroke

  Evidence of clinically definite ischemic stroke confirmed by MRI

  within 6 months after the stent placement

Secondary Outcomes (1)

• bleeding

  within 6 months after stent placement

Other Outcomes (1)

• recurrence of aneurysm, all causes of death

  within 6 months after stent placement

Study Arms (2)

Monitoring Arm

EXPERIMENTAL

dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay(TEG)

Drug: Aspirin and clopidogrel

Conventional Arm

ACTIVE COMPARATOR

fixed dose regiment of both aspirin and clopidogrel in all patients following stent deployment according to international guidelines

Drug: Aspirin and clopidogrel

Interventions

Aspirin and clopidogrel DRUG

modification of aspirin and clopidogrelmaintenance doses based on a biological assay Device:thrombelastography(TEG) point of care assay TEG(Haemoscope Corporation, Niles, IL)

Also known as: Aspirin Enteric Coated Tablets ,Bayer HealthCare AG ;, Plavix

Conventional Arm; Monitoring Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy 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.

  PMID: 23121439 BACKGROUND

MeSH Terms

Conditions

Embolic Stroke

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Youxiang Li, Professor

  Department of neurointervention of Beijing Neurosurgical Institute,capital medical university ,China

  STUDY CHAIR

Central Study Contacts

Hongchao Yang, Doctor

CONTACT

+86010-67098847; yhchao2007@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

CN (1)