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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Disease; Vertebral Artery Stenosis
• Intervention / Treatment: Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lianbo Gao; Phone Number: 13940336399; Email: gaolbdoc@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110032
      • Recruiting
      • the Fourth Affiliated Hospital of China Medical University
      • Contact: Lianbo Gao; Email: gaolbdoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 3 Months DAPT+9 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation	Drug: Ticagrelor; To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.
Active Comparator: Control group; 6 Months DAPT+6 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation	Drug: Ticagrelor; To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.	365±60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.	365±60 Days
Incidence of target vessel-related stroke and neurological death at 1month	30±7 Days
Incidence of stroke and neurological death at 12 month.	365±60 Days
Incidence of all-cause mortality at 12 month.	365±60 days
Incidence of in-stent-stenosis at 12 month (subgroup of imaging follow-up).	365±60 days

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of China Medical University
• Investigators: Principal Investigator: Lianbo Gao, the Fourth Affilicated Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Diseases; Vertebrobasilar Insufficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: Bridge-2023-02-0A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No