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

Brain Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301776
• Other study ID #: Bridge-2023-02-0A
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: The Fourth Affiliated Hospital of China Medical University
• Contact: Lianbo Gao
• Phone: 13940336399
• Email: gaolbdoc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Disease
• Brain Diseases
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Drug:
• Ticagrelor
To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.

Locations

Country	Name	City	State
China	the Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.		365±60 days
Secondary	Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.		365±60 Days
Secondary	Incidence of target vessel-related stroke and neurological death at 1month		30±7 Days
Secondary	Incidence of stroke and neurological death at 12 month.		365±60 Days
Secondary	Incidence of all-cause mortality at 12 month.		365±60 days
Secondary	Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up).		365±60 days