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

May 19, 2022 updated by: Guangzhou Recomgen Biotech Co., Ltd.

The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute ST Elevation Myocardial Infarction(STEMI): a Multi-center, Randomized, Open, Parallel, Non-inferiority, Active Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study includes screening and baseline, randomization & intervention, in-hospital visit, at 30±3 days visit after fibrinolytic therapy.

Following an initial eligibility screening assessment, all eligible patients who have signed the informed consent will be randomly assigned by an interactive Web-based central system for fibrinolytic therapy with either rhTNK-tPA or rt-PA. The standard care should be given to all patients except for the study interventions.

Prior to fibrinolytic administration, enoxaparin (30-mg intravenous) or Un- Fractionated Heparin (maximum 4000U, intravenous) should be administered, combined with antiplatelet therapy consisted of both clopidogrel and aspirin in a 300-mg loading dose followed by routine dosage.

Successful reperfusion according to the clinical evidence (EKG) should be assessed after fibrinolytic therapy.TIMI flow should be assessed for those patients with 24 hours coronary angiography.

MACCE and bleeding events should be followed up and documented during the study until 30 days after fibrinolytic therap. An independent adjudication committee will judge the major endpoint events.

Study Type

Interventional

Enrollment (Actual)

818

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510530
        • Guangzhou Recomgen Biotech Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of acute STEMI（meet with both conditions）:

    • Ischemic chest pain ≥30mins in duration
    • ST elevation ≥0.1 mV in two or more limb ECG leads or ≥0.2 mV in two or more contiguous precordial leads
  2. Onset of continuous ischemic symptoms of STEMI ≤6 hours prior to randomisation
  3. Anticipated Delay to Performing Primary PCI >60mins，or time from hospital arrival to to balloon inflation >90mins
  4. Signed Informed consent received prior to participation the study

Exclusion Criteria:

  1. Non-ST-segment-elevation myocardial infarction or unstable angina
  2. Reinfacrtion
  3. Cardiacgenic shock
  4. Suspected aortic dissection
  5. New left bundle branch block in ECG

  6. Absolute and relative contraindications for Fibrinolytic Therapy in STEMI(referred from 2015 China STEMI Management Guideline）：

    • Severe uncontrolled hypertension (unresponsive to emergency Therapy,BPs > 180 mmHg and/or BPd > 110 mmHg)
    • Any prior ICH,stroke with unknown cause, Ischemic stroke within 3 months
    • Known structural cerebral vascular lesion, malignant intracranial neoplasm
    • Active bleeding, or bleeding diathesis, active peptic ulcer
    • Significant closed-head or facial trauma within 3 months
    • Intracranial or intraspinal surgery within 2 months
    • Recent internal bleeding within 4 weeks
    • Major surgery within 3 weeks, or Traumatic
    • Prolonged cardiopulmonary resuscitation (>10 minutes)
    • Noncompressible vascular punctures within 2 weeks
    • Current use of anticoagulant therapy

  7. Current or with a history of significant diseases：

    • Damage to the central nervous system
    • Severe renal or hepatic dysfunction, blood system diseases,
    • Present with cardiac rupture evidence
    • Acute pericarditis,Subacute bacterial endocarditis, Septic thrombophlebitis or occluded AV cannula at seriously infected site
    • Malignancy
    • High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
    • Diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
    • History of PCI or coronary artery bypass graft（CABG）within 1 month
  8. Administration of fibrinlytic therapy prior to participation
  9. Weight below 50 kg
  10. Known current histroy of fall-down accident

  11. Any other unfavourable conditions for participation：

    • Known participation in other clinical trials
    • Known to allergic to rhTNK-tPA or tPA or relevant vehicle
    • Pregnancy or lactation
    • Mental disorder
    • Present with any unsuitable conditions for participation or completion of the study at the discretion of their treating physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhTNK-tPA
rhTNK-tPA; Dose:16mg; Mode of admin: Single bolus Dose:50mg; Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
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.
Other Names:
  • Recombinant Human TNK Tissue-type Plasminogen Activator
Active Comparator: rt-PA
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.
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.
Other Names:
  • rt-PA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with TIMI grade 2 or 3 flow in the infarct-related artery after therapy (Limited to the subgroup for coronary angiography within 24 hours after therapy)
Time Frame: within 24 hours after therapy
A patent IRA was defined as TIMI grade 2 or 3 flow on the angiogram
within 24 hours after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events)
Time Frame: within 30 days after the start of fibrinolytic therapy
MACCE composited of total death, non-fatal recurrent MI, non-fatal stroke (ischemic and Hemorrhage), PCI for failed reperfusion and PCI for reocclusion
within 30 days after the start of fibrinolytic therapy
The rate of successful reperfusion with clinical evidences
Time Frame: within 24 hours of fibrinolytic therapy
within 24 hours of fibrinolytic therapy
The in-hospital MACCE
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital and 30-day all-cause mortality
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) and 30 days after the start of study interventions
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) and 30 days after the start of study interventions
The in-hospital and 30-day cardiac deaths
Time Frame: during hospitalization (from the date of admission to the date of discharge) and 30 days after the start of study interventions, assessed up to 1 month
during hospitalization (from the date of admission to the date of discharge) and 30 days after the start of study interventions, assessed up to 1 month
The in-hospital recurrent MI
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The 30-day revascularization
Time Frame: 30 days after the start of therapy
30 days after the start of therapy
The in-hospital intracranial hemorrhage (ICH)
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital major GI bleeding events
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital total bleeding events
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)

Other Outcome Measures

Outcome Measure
Time Frame
The frequency and severity of AEs
Time Frame: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
Medical cost within the initial hospitalization
Time Frame: from the date of admission to the date of discharge, assessed up to 1 month
from the date of admission to the date of discharge, assessed up to 1 month
The frequency of re-hospitalizations and emergency room visits
Time Frame: at 30 days after therapy
at 30 days after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Recomgen Biotech Co., Ltd.

Collaborators

Peking University
Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Shubin Qiaos, MD, Chinese Academy of Medical Sciences, Fuwai Hospital
  • Study Director: Qin Yang, MD, Guangzhou Recomgen Biotech Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 12, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute ST Elevation Myocardial Infarction

Clinical Trials on rhTNK-tPA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe