Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window

PHASE4RecruitingINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2025

Conditions
Acute Ischemic Stroke
Interventions
DRUG

rhTNK-tPA

Recombinant human TNK tissue-type plasminogen activator. Patients will receive intravenous rhTNK-tPA (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).

DRUG

Antiplatelet Agents

Aspirin (150-300mg) is offered to patients allocated in the control arm, unless contraindicated. According to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023, 150-300mg aspirin alone is recommended for acute stroke treatment in patients who are otherwise eligible for intravenous thrombolysis or EVT as soon as possible (Class 1 of recommendation, Level A of evidence). The aspirin dose can be changed to 50-300 mg/day after the acute phase. Clopidogrel is indicated as an alternative in case of aspirin intolerance (Class 2 of recommendation, Level C of evidence)

Trial Locations (1)

Unknown

RECRUITING

Xuanwu Hospital, Capital Medical University, Beijing

All Listed Sponsors
collaborator

CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

INDUSTRY

collaborator

Beijing Hospitals Authority

UNKNOWN

lead

Xuanwu Hospital, Beijing

OTHER