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

NCT02835534 | Completed Phase 4 DMC

• 1 other identifier: CP-2015-01
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acute ST elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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)

  A patent IRA was defined as TIMI grade 2 or 3 flow on the angiogram

  within 24 hours after therapy

Secondary Outcomes (10)

• The rate of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events)

  within 30 days after the start of fibrinolytic therapy

• The rate of successful reperfusion with clinical evidences

  within 24 hours of fibrinolytic therapy

• The in-hospital MACCE

  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

  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

  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

Other Outcomes (3)

• The frequency and severity of AEs

  during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)

• Medical cost within the initial hospitalization

  from the date of admission to the date of discharge, assessed up to 1 month

• The frequency of re-hospitalizations and emergency room visits

  at 30 days after therapy

Study Arms (2)

rhTNK-tPA

EXPERIMENTAL

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

rt-PA

ACTIVE COMPARATOR

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

Interventions

rhTNK-tPA DRUG

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

Also known as: Recombinant Human TNK Tissue-type Plasminogen Activator

rhTNK-tPA

alteplase DRUG

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.

Also known as: rt-PA

rt-PA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Onset of continuous ischemic symptoms of STEMI ≤6 hours prior to randomisation
• Anticipated Delay to Performing Primary PCI \>60mins，or time from hospital arrival to to balloon inflation \>90mins
• Signed Informed consent received prior to participation the study

You may not qualify if:

• Non-ST-segment-elevation myocardial infarction or unstable angina
• Reinfacrtion
• Cardiacgenic shock
• Suspected aortic dissection
• New left bundle branch block in ECG
• 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)

Sponsors & Collaborators

• CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Peking University: collaborator

Study Sites (1)

Guangzhou Recomgen Biotech Co., Ltd.

Guangzhou, Guangdong, 510530, China

Location

Related Publications (2)

• Zhao X, Zhu Y, Zhang Z, Tao G, Xu H, Cheng G, Gao W, Ma L, Qi L, Yan X, Wang H, Xia Q, Yang Y, Li W, Rong J, Wang L, Ding Y, Guo Q, Dang W, Yao C, Yang Q, Gao R, Wu Y, Qiao S. Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial. Chin Med J (Engl). 2024 Feb 5;137(3):312-319. doi: 10.1097/CM9.0000000000002731. Epub 2023 Jun 2.

  PMID: 37265385 DERIVED

• Wang HB, Ji P, Zhao XS, Xu H, Yan XY, Yang Q, Yao C, Gao RL, Wu YF, Qiao SB. Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) versus alteplase (rt-PA) as fibrinolytic therapy for acute ST-segment elevation myocardial infarction (China TNK STEMI): protocol for a randomised, controlled, non-inferiority trial. BMJ Open. 2017 Sep 18;7(9):e016838. doi: 10.1136/bmjopen-2017-016838.

  PMID: 28928186 DERIVED

MeSH Terms

Interventions

Tissue Plasminogen Activator

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Shubin Qiaos, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Qin Yang, MD

  CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: July 18, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

CN (1)