Comparing 3-month versus 6-month dual antiplatelet therapy after Bridge implantation for vertebral artery stenosis

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

This study is testing whether taking dual antiplatelet therapy for 3 months or 6 months after a specific procedure for blocked vertebral arteries helps prevent strokes and other serious health issues in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Fourth Affiliated Hospital of China Medical University (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06301776 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of two different durations of dual antiplatelet therapy followed by ticagrelor in patients undergoing Bridge implantation for symptomatic vertebral artery stenosis. Participants will be randomly assigned to receive either 3 months or 6 months of dual antiplatelet therapy before transitioning to ticagrelor monotherapy. The primary outcome will be the incidence of non-fatal ischemic stroke, transient ischemic attack (TIA), and all-cause mortality at a 12-month follow-up. The study will take place at the Fourth Affiliated Hospital of China Medical University.

Who should consider this trial

Good fit: Ideal candidates include patients with symptomatic vertebral artery stenosis who have experienced ischemic strokes or TIAs despite prior antithrombotic treatment.

Not a fit: Patients with significant comorbidities or complex vascular conditions that complicate treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimal antiplatelet therapy duration, potentially reducing the risk of serious vascular events in patients with vertebral artery stenosis.

How similar studies have performed: While there have been studies on antiplatelet therapy duration, this specific comparison of 3-month versus 6-month therapy in the context of Bridge implantation is relatively novel.

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

Where this trial is running

Shenyang, Liaoning

• the Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Lianbo Gao — the Fourth Affilicated Hospital of China Medical University
• Study coordinator: Lianbo Gao

Conditions Brain Disease; Vertebral Artery Stenosis