MedTrace Logo

The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI

NCT02835534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2022-05-25

No results posted yet for this study

Summary

This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients. It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.

Conditions

  • Acute ST Elevation Myocardial Infarction

Interventions

DRUG

rhTNK-tPA

Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.

DRUG

alteplase

Dose:50mg; Mode of admin: administered as an 8-mg initial IV bolus followed by an infusion of 42 mg over the next 90 minutes Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Peking University

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • Shubin Qiaos, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

  • Qin Yang, MD · CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-10-31
Completion
2020-01-31

Countries

  • China

Study Locations

More Related Trials

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 NCT02835534 on ClinicalTrials.gov