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

NCT06301776 | Recruiting DMC

• 1 other identifier: Bridge-2023-02-0A
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of the composite endpoint of non-fatal ischaemic Stroke, TIA, and all-cause mortality at 12-months.

  365±60 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Ticagrelor

Control group

ACTIVE COMPARATOR

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

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Fourth Affiliated Hospital of China Medical University: lead

Study Sites (1)

the Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110032, China

RECRUITING

MeSH Terms

Conditions

Brain Diseases; Vertebrobasilar Insufficiency

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Lianbo Gao

  the Fourth Affilicated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianbo Gao

CONTACT

13940336399; gaolbdoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: December 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

CN (1)