Actively Recruiting
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
Led by The Fourth Affiliated Hospital of China Medical University · Updated on 2024-03-08
560
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are suitable for Bridge implantation
- Symptomatic vertebral artery stenosis with a history of posterior circulation-related ischaemic stroke or TIA despite use of at least one antithrombotic medication and risk factor intervention
- Responsible vertebral artery stenosis (≥70% stenosis by NASCET method) confirmed by DSA imaging
- Patient or authorized person understands the study purpose, agrees to participate, and signs informed consent form
You will not qualify if you...
- Modified Rankin Scale score ≥3
- Presence of tandem stenotic lesions in the target area or combined basilar artery stenosis
- Presence of two or more stenotic cerebrovascular lesions requiring concurrent intervention
- Severe tortuosity or calcification of target vessel or abnormal vascular variants preventing catheter or stent implantation
- Lesions or stenosis too large beyond stent specifications
- Non-atherosclerotic stenosis such as atrial fibrillation, vasculitis, arterial entrapment, smoky disease, active arteritis, or unknown cause
- Contraindications to heparin, aspirin, tegretol, clopidogrel, or other antiplatelet drugs; inability to tolerate anticoagulant or antiplatelet therapy
- Intracranial haemorrhage within 3 months
- Myocardial infarction or large cerebral infarction within 2 weeks
- Other intracranial diseases such as aneurysm, arteriovenous malformation, intracranial tumour, infection
- Active bleeding or high risk of haemorrhage (e.g., active peptic ulcer, gastrointestinal bleeding risk, malignant tumours)
- Severe cardiac, hepatic, splenic, pulmonary, or renal impairment
- Allergy or intolerance to contrast media, rapamycin and derivatives, cobalt-based alloys, or polylactic acid
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110032
Actively Recruiting
Research Team
L
Lianbo Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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