Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (1)Age≥18 years old; (2)Acute ischemic stroke symptom onset within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to last-seen normal time; (3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke; (4)Pre-stroke modified Rankin scale (mRS) score ≤1; (5)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms; (6)Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70mL, mismatch rate \>1.2, mismatch volume \>10mL); (7)Written informed consent from patients or their legally authorized representatives.

Locations
Other Locations
China
Beijing tiantan hospital
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital, School of Medicine, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Jiuquan city people's hospital
RECRUITING
Jiuquan
Jiyuan Traditional Chinese Medicine Hospital
RECRUITING
Jiyuan
The first people hospital of lingbao
RECRUITING
Lingbao
Hai'an People's Hospital
RECRUITING
Nantong
Xingtang People's Hospital
RECRUITING
Shijiazhuang
Contact Information
Primary
Yunyun Xiong
xiongyunyun@bjtth.org
86-10-59978350
Backup
Ziqi Xu
zyxuziqi@zju.edu.cn
86-0571-87236666
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 596
Treatments
Experimental: Tenecteplase (0.25 mg/kg)
Tenecteplase (0.25 mg/kg, max 25 mg)
Active_comparator: Standard medical treatment
Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone
Related Therapeutic Areas
Sponsors
Collaborators: First Affiliated Hospital of Zhejiang University, Chinese Stroke Association
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov