NCT06683300

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 520 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vertebral Artery Stenosis

Interventions

Type	Name	Description
DRUG	DAPT for 3 months after vertebral artery stenting	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China