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

NCT ID: NCT06301776

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2026-06-30

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.

Conditions

Brain Disease; Vertebral Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

3 Months DAPT+9 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.

Control group

6 Months DAPT+6 months ticagrelor monotherapy after Bridge(MicroPort NeuroTech, Shanghai, China) implantation

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.

Interventions

Ticagrelor

To compare the safety and efficacy of different DAPT duration combined with ticagrelor monotherapy.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Lianbo Gao

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lianbo Gao

Role: PRINCIPAL_INVESTIGATOR

the Fourth Affilicated Hospital of China Medical University

Locations

the Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianbo Gao

Role: CONTACT

gaolbdoc@163.com

13940336399

Facility Contacts

Lianbo Gao

Role: primary

gaolbdoc@163.com

Other Identifiers

Bridge-2023-02-0A

Identifier Type: -

Identifier Source: org_study_id