Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China.

Currently, there is no consensus regarding the duration of DAPT after drug-eluting stent treatment for vertebral artery stenosis(VAS). The objective of this study is to standardize clinical medication by shortening the duration of DAPT, thereby reducing the bleeding risk and medication burden for patients, while ensuring that there is no increase in ischemic events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old, gender unlimited;

Based on clinical and imaging evidence, the investigators identified patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents;

Patients or their guardians sign informed consent.

Disqualifiers

Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;

Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;

Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;

Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;

Trial population

Patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • DAPT for 3 months after vertebral artery stenting

    Drug

    After implantation of a drug-eluting stent in the vertebral artery, dual antiplatelet therapy (DAPT) were administered for 3 months. The types of antiplatelet medications are not limited, with the standard regimen consisting of aspirin 100 mg once daily combined with either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily. Additional antiplatelet agents such as indobufen may also be considered acceptable.

Treatment groups

520 Participants
are divided into 1 treatment group
Group A: 3 months DAPT1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of ischemic stroke in the territory of the target artery within 1 year

The primary endpoint was defined as occurrence of ischemic stroke events in the target arterial territory, excluding transient ischemic attacks.

Time frame
12 months after stent implantation

Secondary outcomes

1

Occurrence of Periprocedural events

Periprocedural events defined as occurrence of transient ischemic attack (TIA), ischemic stroke and all-cause death.

Time frame
within 30 days after stent implantation
2

Occurrence of Bleeding Events within 1 year

Bleeding events are defined as gastrointestinal hemorrhage, gingival hemorrhage, conjunctival hemorrhage, intraocular hemorrhage, nasal hemorrhage, hemoptysis, cerebral hemorrhage(such as subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), or subdural hematoma (SDH)), bleeding at puncture sites, intraperitoneal bleeding, and skin bleeding, among others.

Time frame
12 months after stent implantation
3

Occurrence of TIA events related to the target territory within 1 year

The outcome defined as temporary neurological symptoms caused by TIA that related to the target lesion judged by physicians.

Time frame
12 months after stent implantation
4

Occurrence of disabling and fatal stroke events within 1 year

Disabling and fatal stroke are defined as stroke that results in severe disability or death.

Time frame
12 months after stent implantation

Other outcomes

Sponsors and contacts

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