Acute ST Elevation Myocardial InfarctionPhase 4NCT02835534
The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
A Phase 4 study testing rhTNK-tPA and alteplase in people with Acute ST Elevation Myocardial Infarction, run by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute ST Elevation Myocardial Infarction
- What is being tested?
- rhTNK-tPA and alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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）：
Show all 35Show fewer
- 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
- 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
- Administration of fibrinlytic therapy prior to participation
- Weight below 50 kg
- Known current histroy of fall-down accident
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute ST Elevation Myocardial Infarction
- Being tested
- rhTNK-tPA, alteplase
- Keywords
- acute ST elevation myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPADrug
Also called Recombinant Human TNK Tissue-type Plasminogen Activator
Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
alteplaseDrug
Also called rt-PA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24 hours after therapy
Secondary outcomes (10)
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
Measured: within 30 days after the start of fibrinolytic therapy
The rate of successful reperfusion with clinical evidences
Measured: within 24 hours of fibrinolytic therapy
The in-hospital MACCE
Measured: 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
Measured: 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
Measured: 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
Measured: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The 30-day revascularization
Measured: 30 days after the start of therapy
The in-hospital intracranial hemorrhage (ICH)
Measured: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital major GI bleeding events
Measured: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
The in-hospital total bleeding events
Measured: during hospitalization (from the date of admission to the date of discharge, assessed up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shubin Qiaos, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalQin Yang, MD, Study director, CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835534
- Sponsor's protocol ID
- CP-2015-01
- Status last verified
- May 2022
- First submitted
- 12 Jun 2016
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37265385Wang 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.
PubMed 28928186
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02835534
- Acronym / sponsor ID
- CP-2015-01
- Conditions
- Acute ST Elevation Myocardial Infarction
- Keywords
- acute ST elevation myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Peking University
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTNK-tPA | Experimental | Drug: rhTNK-tPArhTNK-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: alteplaseDrug: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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (35 listed)
- Non-ST-segment-elevation myocardial infarction or unstable angina
- Reinfacrtion
- Cardiacgenic shock
- Suspected aortic dissection
- New left bundle branch block in ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTNK-tPAAlso: Recombinant Human TNK Tissue-type Plasminogen ActivatorDose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy. | Drug | rhTNK-tPA |
| alteplaseAlso: rt-PADose: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 | rt-PA |
Primary outcome
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
10 secondary outcomes
The rate of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events)
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 37265385Zhao 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.
- Derived from this study: PubMed 28928186Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubin Qiaos, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Qin Yang, MD study director
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhTNK-tPA and alteplase in people with Acute ST Elevation Myocardial Infarction, run by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835534, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.