Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)

Summary

To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.

Conditions

• Acute Ischemic Stroke

Interventions

DRUG

TNK-tPA

Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol

Sponsors & Collaborators

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

  collaborator INDUSTRY

• The First Hospital Of Qiqihar

  collaborator UNKNOWN

• Hebei Medical University Third Hospital

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Inner Mongolia Baogang Hospital

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Baotou Central Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Meng Wang, MD,ph.D · 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

2018-05-12

Primary Completion

2020-05-30

Completion

2020-07-10

Countries

• China

Study Locations