A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dua… (NCT06301776) | Clinical Trial Compass
RecruitingNot Applicable
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
China560 participantsStarted 2023-12-05
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
* mRS≥3
* 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…
What they're measuring
1
Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.
Timeframe: 365±60 days
Trial details
NCT IDNCT06301776
SponsorThe Fourth Affiliated Hospital of China Medical University