Clinical trial NCT06301776: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Disease
Vertebral Artery Stenosis
Lead sponsor: The Fourth Affiliated Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

* 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 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

Primary outcomes:
measure: Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.
timeFrame: 365±60 days
Secondary outcomes:
measure: Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.
timeFrame: 365±60 Days
measure: Incidence of target vessel-related stroke and neurological death at 1month
timeFrame: 30±7 Days
measure: Incidence of stroke and neurological death at 12 month.
timeFrame: 365±60 Days
measure: Incidence of all-cause mortality at 12 month.
timeFrame: 365±60 days
measure: Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up).
timeFrame: 365±60 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the Fourth Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: the Fourth Affilicated Hospital of China Medical University
name: Lianbo Gao
role: PRINCIPAL_INVESTIGATOR
References: