A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge

The Fourth Affiliated Hospital of China Medical University1 site in 1 country560 target enrollmentDecember 5, 2023

ConditionsBrain Disease Vertebral Artery Stenosis

InterventionsTicagrelor

DrugsTicagrelor

Overview

Phase: Not Applicable
Intervention: Ticagrelor
Conditions: Brain Disease
Sponsor: The Fourth Affiliated Hospital of China Medical University
Enrollment: 560
Locations: 1
Primary Endpoint: Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy.

Registry

clinicaltrials.gov

Start Date

December 5, 2023

End Date

June 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Fourth Affiliated Hospital of China Medical University

Responsible Party

Principal Investigator

Lianbo Gao

Chief Physician

The Fourth Affiliated Hospital of China Medical University

Eligibility Criteria

Inclusion Criteria

•Patients who are suitable for Bridge implantation
•Symptomatic vertebral artery stenosis with a history of posterior circulation-related ischaemic stroke or TIA despite the use of at least one antithrombotic medications and intervention for risk factors
•Responsible vertebral artery stenosis (≥70% stenosis, measured by the NASCET method ) confirmed by DSA imaging
•The patient and/or his/her authorised person understands the purpose of the study, agrees to participate in the study and signs the informed consent form

Exclusion Criteria

•Presence of tandem stenotic lesions in the target lesion areaor combined basilar artery stenosis Presence of ≥2 stenotic cerebrovascular lesions requiring concurrent intervention The presence of severe tortuosity or calcification of the target vessel, or the presence of extensive abnormal vascular structural variants that are difficult for catheters or stents to pass or cannot be implanted
•Lesions or stenosis that is too large and beyond the specification of the stent
•Non-atherosclerotic stenosis such as atrial fibrillation, vasculitis stenosis, arterial entrapment, smoky disease, active phase of arteritis, or unknown cause
•Contraindication to heparin, aspirin, tegretol, clopidogrel, or other antiplatelet drugs, and those who cannot tolerate anticoagulant and antiplatelet drug therapy
•Have had intracranial haemorrhage within 3 months
•Had a myocardial infarction or large cerebral infarction within 2 weeks
•Accompanied by other intracranial disease such as aneurysm, arteriovenous malformation, intracranial tumour, intracranial infection, etc
•Presence of active bleeding or extremely dangerous risk of haemorrhage (e.g. active peptic ulcer disease, gastrointestinal lesions with bleeding risk, malignant tumours with bleeding risk, etc.)
•Severe cardiac, hepatic, splenic, pulmonary, or renal impairment, or allergy or intolerance to contrast media, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, or polylactic acid

Arms & Interventions

Experimental group

3 Months DAPT+9 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation

Intervention: Ticagrelor

Control group

6 Months DAPT+6 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation

Intervention: Ticagrelor

Outcomes

Primary Outcomes

Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.

Time Frame: 365±60 days

Secondary Outcomes

Incidence of all-cause mortality at 12 month.(365±60 days)
Incidence of target vessel-related stroke and neurological death at 1month(30±7 Days)
Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up).(365±60 days)
Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.(365±60 Days)
Incidence of stroke and neurological death at 12 month.(365±60 Days)