Actively Recruiting
A Prospective, Multicenter, Open-label, Randomized Controlled Trial Comparing 3-month vs 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Bridge Implantation
Led by The Fourth Affiliated Hospital of China Medical University · Updated on 2024-03-08
560
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different durations of dual-antiplatelet therapy (DAPT) followed by ticagrelor monotherapy in patients with symptomatic vertebral artery stenosis who have undergone Bridge implantation. The study compares the incidence of a combined outcome including non-fatal ischemic stroke, transient ischemic attack (TIA), and all-cause mortality over a 12-month follow-up period. This trial aims to determine the optimal length of DAPT to improve patient outcomes after the procedure. Participants are randomly assigned to one of two treatment groups: one group receives 3 months of dual-antiplatelet therapy followed by 9 months of ticagrelor alone, while the other group receives 6 months of dual-antiplatelet therapy followed by 6 months of ticagrelor monotherapy. The Bridge device (MicroPort NeuroTech, Shanghai, China) is implanted in all participants as part of the treatment for vertebral artery stenosis. Throughout the study, participants will be monitored regularly to assess the occurrence of stroke, TIA, mortality, bleeding events, and neurological outcomes at various time points, including 1 month and 12 months after treatment. Imaging follow-up will evaluate in-stent stenosis in a subgroup of patients. The primary outcome is measured at 12 months, and safety and efficacy are closely observed during this period. The total study duration for each participant is approximately one year.
CONDITIONS
Brief 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 suitable for Bridge implantation
- Symptomatic vertebral artery stenosis with history of posterior circulation-related ischemic stroke or TIA despite antithrombotic treatment
- Vertebral artery stenosis of 70% or more confirmed by imaging
- Participant or authorized person understands study purpose and consents to participate
You will not qualify if you...
- Modified Rankin Scale score of 3 or higher
- Presence of tandem stenotic lesions or basilar artery stenosis requiring intervention
- Severe vessel tortuosity, calcification, or abnormal vascular variants preventing catheter or stent placement
- Lesions too large for the stent specifications
- Non-atherosclerotic stenosis causes (e.g., atrial fibrillation, vasculitis)
- Contraindications or intolerance to heparin, aspirin, clopidogrel, or other antiplatelet/anticoagulant drugs
- Intracranial hemorrhage within 3 months
- Myocardial infarction or large cerebral infarction within 2 weeks
- Other intracranial diseases like aneurysm, infection, tumor
- Active bleeding or high risk of bleeding
- Severe cardiac, hepatic, splenic, pulmonary, or renal impairment
- Allergy to contrast media, rapamycin or related substances, cobalt alloys, or polylactic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy after Bridge implantation, with treatment duration depending on randomization to either 3-month DAPT plus 9-month ticagrelor or 6-month DAPT plus 6-month ticagrelor.
Regular visits according to treatment schedule
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
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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