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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Peking University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) | A patent IRA was defined as TIMI grade 2 or 3 flow on the angiogram | within 24 hours after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Diagnosis of acute STEMI(meet with both conditions):
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
Exclusion Criteria:
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):
Current or with a history of significant diseases:
Administration of fibrinlytic therapy prior to participation
Weight below 50 kg
Known current histroy of fall-down accident
Any other unfavourable conditions for participation:
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| Name | Affiliation | Role |
|---|---|---|
| Shubin Qiaos, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Qin Yang, MD | CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Recomgen Biotech Co., Ltd. | Guangzhou | Guangdong | 510530 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37265385 | Derived | 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. | |
| 28928186 |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| 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. |
|
|
| 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 |
| The in-hospital recurrent MI | during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) |
| The 30-day revascularization | 30 days after the start of therapy |
| The in-hospital intracranial hemorrhage (ICH) | during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) |
| The in-hospital major GI bleeding events | during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month) |
| The in-hospital total bleeding events | during 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 |
| 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. |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |