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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

NCT04797013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1430

Last updated 2023-01-17

No results posted yet for this study

Summary

A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

rt-PA

Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.

DRUG

rhTNK-tPA

Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.

Sponsors & Collaborators

  • CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

    collaborator INDUSTRY

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Wei Sun · IRB of Beijing Tiantan Hospital,Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-12
Primary Completion
2022-05-29
Completion
2022-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797013 on ClinicalTrials.gov