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

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ClinicalTrials.gov Identifier: NCT02835534
Recruitment Status : Unknown
Verified July 2016 by Guangzhou Recomgen Biotech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Peking University
Information provided by (Responsible Party):
Guangzhou Recomgen Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 12, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date July 18, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • The proportion of patients with TIMI grade 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 ]
  • The rate of successful reperfusion with clinical evidences [ Time Frame: 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) ]
  • 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 ]
  • 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 ]
  • The in-hospital recurrent MI [ Time Frame: 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2016)
  • 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) ]
  • Medical cost within the initial hospitalization [ Time Frame: 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute ST Elevation Myocardial Infarction
Intervention  ICMJE
  • 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 Name: Recombinant Human TNK Tissue-type Plasminogen Activator
  • 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 Name: rt-PA
Study Arms  ICMJE
  • 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.
    Intervention: Drug: rhTNK-tPA
  • 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.
    Intervention: Drug: alteplase
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
6200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02835534
Other Study ID Numbers  ICMJE CP-2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Guangzhou Recomgen Biotech Co., Ltd.
Study Sponsor  ICMJE Guangzhou Recomgen Biotech Co., Ltd.
Collaborators  ICMJE
  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Peking University
Investigators  ICMJE
Principal Investigator: Shubin Qiaos, MD Chinese Academy of Medical Sciences, Fuwai Hospital
Study Director: Qin Yang, MD Guangzhou Recomgen Biotech Co., Ltd.
PRS Account Guangzhou Recomgen Biotech Co., Ltd.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP