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A Pilot Dose-Escalation Safety Study of adjunctive intra-arterial Tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke

A Pilot Dose-Escalation Safety Study of adjunctive intra-arterial Tenecteplase after successful endovascular thrombectomy in patients with large vessel occlusion stroke

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073787
Enrollment
Unknown
Registered
2023-07-20
Start date
2023-07-20
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Experimental group:Intra-arterial Tenecteplase thrombolysis in occluded arteries after successful endovascular treatment. The dose gradient of Tenecteplase is set as 1/8, 1/4, 1/2, 3/4 of the intraven

Sponsors

The First Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 18 years; 2. The time from onset to randomization was within 24 hours; 3. Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA (Including intracranial segment of internal carotid artery and M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4. Alberta Stroke Program Early Diagnosis (ASPECTS) score = 6 based on NCCT; 5.NIHSS score = 6; 6. Successful endovascular thrombectomy (eTICI 2b50-3); 7. Total pass numbers = 3; 8.Written informed consent signed by patients or their family members

Exclusion criteria

Exclusion criteria: 1. NIHSS score = 25; 2.Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 3.Treated by intravenous thrombolysis; 4.Prestroke mRS score >= 2; 5.Intraoperative DSA angiography suggests vessel penetration, entrapment, and extravasation of contrast medium; 6.Pregnant or lactating patients; 7.Allergic to contrast agents or Tenecteplase; 8.Systolic pressure greater than 185 mmHg or diastolic pressure greater than 110 mmHg after aggressive treatment; 9.Genetic or acquired bleeding disposition with anticoagulation factor deficiency or already taking oral anticoagulants within 48 hours and INR > 1.7; 10.Blood glucose 22.2 mmol/L (400 mg/dl), platelets 220µmol/L (2.5mg/dl)); 13.Any terminal illness with a life expectancy of less than 6 months; 14.Intracranial aneurysm, arteriovenous malformation; 15.Brain tumors with occupying effect on imaging; 16.Puncture to recanalization time >90min; 17.Current participation in another clinical trial; 18.Unlikely to be available for 90-day follow-up.

Design outcomes

Primary

MeasureTime frame
Symptomatic intracerebral hemorrhage (sICH) rate within 24 h;

Secondary

MeasureTime frame
90-day modified RANKIN scale (mRS) score 0-1 (%);Proportion of patients with functional independence (mRS score 0 to 2) at 90 days;Proportion of patients with angiographic changes on the eTICI score after Intra-arterial Tenecteplase thrombolysis;Changes in the national institutes of health stroke scale (NIHSS) score 5-7 days after surgery;Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) at 90 days; mortality at 90 days;

Countries

China

Contacts

Public ContactZhou zhenhua

The First Affiliated Hospital of the Army Medical University

exploiter001@126.com+86 135 9414 5356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026