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NCT Number: NCT06683300

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

As the drug-eluting stents (DES) with indications for vertebral artery treatment have been officially approved in China, DES has gradually been widely used in the treatment of vertebral artery stenosis. There is increasing clinical attention towards the duration of dual antiplatelet therapy (DAPT) following stenting.

Currently, there is limited evidence regarding the optimal DAPT duration following endovascular treatment for vertebral artery stenosis. Therefore, clinical practice typically relies on experiences derived from treatments for coronary, carotid, or lower limb artery diseases, with a conventional recommendation of 6 to 12 months of antiplatelet therapy post-stent implantation.

Evidence obtained from coronary stents shows that the short-term DAPT strategy of 1-3 months after PCI in the new generation of DES can significantly reduce the incidence of severe bleeding without increasing ischemic events compared with the standard DAPT strategy of 7-12 months, especially for non-acute elective surgery patients who are similar to those with vertebral artery stenosis stents.

This study employs new-generation Co-Cr fluoropolymer DES to evaluate the balance between ischemic and bleeding complications by shortening the DAPT duration, with the ultimate aim of maximizing patient benefits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Interventional or surgical procedures are planned within 90 days;
  • Known contraindications to heparin, rapamycin, anesthesia and contrast agents;
  • Life expectancy is less than 12 months;
  • The researcher considers it inappropriate to participate in this study.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months after stent implantation

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

Secondary outcomes

  1. Occurrence of Periprocedural events

    Time frame: within 30 days after stent implantation

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

  2. Occurrence of Bleeding Events within 1 year

    Time frame: 12 months after stent implantation

    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.

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

    Time frame: 12 months after stent implantation

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

  4. Occurrence of disabling and fatal stroke events within 1 year

    Time frame: 12 months after stent implantation

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

  5. AEs and SAEs

    Time frame: in 12 months

  6. Occurrence of residual stenosis after the procedure

    Time frame: At the end of the procedure

    Degree of residual stenosis was measured and calculated according to the methods of the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial.

  7. Rate of In-stent restenosis (ISR) within 12 months

    Time frame: 12 months after stent implantation

    The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss.

  8. modified Rankin Scale score at 1 year

    Time frame: 12 months after stent implantation

    The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;

    • No significant disability;
    • Slight disability;
    • Moderate disability;
    • Moderately severe disability;
    • Severe disability; 6 -Dead. A higher score indicates a poorer outcome.
  9. The National Institutes of Health Stroke Scale (NIHSS) score at 1 year

    Time frame: 12 months after stent implantation

    NIHSS is a standardized scoring system used to measure the severity of neurological deficits caused by a stroke. It assesses various aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. The scale ranges from 0 to 42, with higher scores indicating more severe strokes.

  10. EQ-5D score at 1 year

    Time frame: 12 months after stent implantation

    The EQ-5D is a standardized questionnaire used to measure health-related quality of life. It assesses five dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. Each dimension is scored from 1 to 3, with 1 being no problems, 2 being some or moderate problems, and 3 being severe or extreme problems.

Study contacts

Contact information is provided by the study sponsor or research team.

Baixue Jia, MD

CONTACT

[email protected]

+86-15010125093

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Acronym: M Short DAPT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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