ST-segment Elevation Myocardial Infarction (STEMI)Phase 4H2-THROMBUSNCT06769256
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
A Phase 4 study testing rhTNK-tPA, 4-8 mg and Tirofiban in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- rhTNK-tPA, 4-8 mg and Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old;
- STEMI within 12 hours of onset;
- TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
- Radial artery access
Who cannot join
- A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
- Known or suspected old myocardial infarction of target vessels
- Rescue PCI
- Cardiogenic shock
- Contraindications to Tirofiban or rhTNK-tPA
- Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate <30ml/min/1.73m2, or on dialysis)
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- Prolonged (> 10 minutes) cardiopulmonary resuscitation
- Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
- Severe chronic obstructive pulmonary disease or respiratory failure
- Severe infection
- Neurological disorders
- Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
You Zhang, +8637158681037
About this study
Official title: Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study
The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:
- Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?
- Does intracoronary rhTNK-tPA increase the incidence of bleeding events?
This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.
- Being tested
- rhTNK-tPA, 4-8 mg, Tirofiban
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPA, 4-8 mgDrug
Intracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced.
TirofibanDrug
Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary rhTNK-tPA | Experimental | Not described Receives: Drug: rhTNK-tPA, 4-8 mg |
| Intracoronary Tirofiban | Active comparator | Not described Receives: Drug: Tirofiban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected TIMI frame count (CTFC)
Measured: At the end of Percutaneous Coronary Intervention procedure
Secondary outcomes (5)
TIMI flow grade
Measured: At the end of Percutaneous Coronary Intervention procedure
Complete ST-segment resolution (STR)
Measured: 1 hour post PCI procedure
Left ventricular ejection fraction (LVEF)
Measured: Baseline, 1 month, 6 months and 12 months
A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Measured: 1 month, 6 months and 12 months
Bleeding events according to the BARC bleeding classification
Measured: At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769256
- Sponsor's protocol ID
- HenanICE202412
- Acronym
- H2-THROMBUS
- Status last verified
- May 2026
- First submitted
- 26 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study
- ClinicalTrials.gov ID
- NCT06769256
- Acronym / sponsor ID
- H2-THROMBUS / HenanICE202412
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- 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.
The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:
- Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?
- Does intracoronary rhTNK-tPA increase the incidence of bleeding events?
This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary rhTNK-tPA | Experimental | Drug: rhTNK-tPA, 4-8 mg |
| Intracoronary Tirofiban | Active comparator | Drug: Tirofiban |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old;
- STEMI within 12 hours of onset;
- TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
- Radial artery access
Key exclusion criteria (13 listed)
- A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
- Known or suspected old myocardial infarction of target vessels
- Rescue PCI
- Cardiogenic shock
- Contraindications to Tirofiban or rhTNK-tPA
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-tPA, 4-8 mgIntracoronary influsion of rhTNK-tPA (4 mg). After 10 minutes of administration, 4 mg may be given again if the thrombus burden is not significantly reduced. | Drug | Intracoronary rhTNK-tPA |
| TirofibanIntracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer | Drug | Intracoronary Tirofiban |
Primary outcome
Corrected TIMI frame count (CTFC)
Time frame: At the end of Percutaneous Coronary Intervention procedure
5 secondary outcomes
TIMI flow grade
Time frame: At the end of Percutaneous Coronary Intervention procedure
Complete ST-segment resolution (STR)
Time frame: 1 hour post PCI procedure
Left ventricular ejection fraction (LVEF)
Time frame: Baseline, 1 month, 6 months and 12 months
A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Time frame: 1 month, 6 months and 12 months
Bleeding events according to the BARC bleeding classification
Time frame: At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
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, 4-8 mg and Tirofiban in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Henan Institute of Cardiovascular Epidemiology 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact You Zhang (+86 37158681037, 13598019682@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected TIMI frame count (CTFC) (time frame: At the end of Percutaneous Coronary Intervention procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.