Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual

Status Recruiting

Clinical Trial Summary

The primary goal of the trial is to investigate whether the experimental arms (receiving the P2Y12 inhibitor Ticagrelor) compared with the control arm (taking dual antiplatelet therapy) could reduce bleeding complications in patients with intracranial aneurysms undergoing Stent-Assisted Coiling.

Clinical Trial Description

Bleeding complications associated with the use of DAPT have been of great concern, with up to one-third of PCI patients treated with DAPT previously reported to suffer from nuisance bleeding. Once any of these bleeding complications occur, adherence to the DAPT regimen may become difficult. Antiplatelet agents are necessary for patients undergoing stent-assisted spring coil embolisation of intracranial aneurysms and are key to reducing thrombosis leading to ischaemic stroke events in post-procedural patients. Currently neither long-term DAPT nor short-duration DAPT followed by aspirin monotherapy is fully satisfactory. Patients with aneurysms without underlying intracranial atherosclerotic disease have relatively lower ischaemic risk factors, and antiplatelet medication after stenting remains to be improved. Ticagrelor monotherapy was associated with a lower risk of major bleeding and no measurable increase in ischaemic events after a short course of 1- or 3-month DAPT. The study indicated no difference in stroke or death between mono- and dual-antiplatelet therapy after carotid artery placement, and P2Y12 inhibitor monotherapy may be an effective strategy to reduce severe bleeding complications while preserving ischemic benefits for patients. This study investigates the comparative efficacy and safety of stent-assisted coiling therapy for intracranial aneurysms after ticagrelor monotherapy as an alternative to dual antiplatelet therapy, to reduce the incidence of bleeding complications in patients, and thus to improve the antiplatelet strategy after stent-assisted coiling therapy for intracranial aneurysms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06015477
Study type	Interventional
Source	The First Affiliated Hospital with Nanjing Medical University
Contact	Hua Lu, Doctor
Phone	18761671021
Email	luhua@njmu.edu.cn
Status	Recruiting
Phase	N/A
Start date	January 1, 2024
Completion date	July 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04870047` - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation	N/A
Recruiting	`NCT05968053` - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting	`NCT05665309` - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor	N/A
Completed	`NCT02783339` - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn	`NCT01194388` - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed	`NCT00071565` - Familial Intracranial Aneurysm Study II	N/A
Recruiting	`NCT05409989` - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study	N/A
Completed	`NCT03680742` - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm	N/A
Completed	`NCT04872842` - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated	`NCT02532517` - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device	N/A
Completed	`NCT03663257` - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting	`NCT06189950` - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE	N/A
Recruiting	`NCT05608122` - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting	`NCT03661463` - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).	Phase 2
Completed	`NCT02609867` - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)	N/A
Active, not recruiting	`NCT02292017` - Prospective Packing Density With Target Coils I	N/A
Active, not recruiting	`NCT01872741` - Minipterional Versus Pterional Craniotomy	N/A
Completed	`NCT00993057` - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia	Early Phase 1
Completed	`NCT00777088` - Pipeline for Uncoilable or Failed Aneurysms	N/A
Completed	`NCT00777907` - Complete Occlusion of Coilable Aneurysms	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Unruptured Intracranial Aneurysm — SAC-TIDE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms