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Compares treatment options for ST-segment Elevation Myocardial Infarction (STEMI)
Official title Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
ClinicalTrials.gov ID: NCT06769256
What this study is testing
What is rhTNK-tPA, 4-8 mg?
rhTNK-tPA, 4-8 mg is an investigational medicine, being studied as a potential treatment for st-segment elevation myocardial infarction (stemi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.