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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Fourth Affiliated Hospital of China Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ticagrelor

    Drug

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

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
365±60 days

Secondary outcomes

1

Incidence of the composite endpoint of major bleeding and hemorrhagic stroke at 12-months.

Time frame
365±60 Days
2

Incidence of target vessel-related stroke and neurological death at 1month

Time frame
30±7 Days
3

Incidence of stroke and neurological death at 12 month.

Time frame
365±60 Days
4

Incidence of all-cause mortality at 12 month.

Time frame
365±60 days

Other outcomes

Sponsors and contacts

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