Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Institute of Cardiovascular Epidemiology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
rhTNK-tPA, 4-8 mg
DrugIntracoronary 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.
Tirofiban
DrugIntracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intracoronary rhTNK-tPAExperimental treatment 1 intervention
Group B: Intracoronary TirofibanActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Corrected TIMI frame count (CTFC)
Time frame
At the end of Percutaneous Coronary Intervention procedureSecondary outcomes
1
TIMI flow grade
Time frame
At the end of Percutaneous Coronary Intervention procedure2
Complete ST-segment resolution (STR)
Time frame
1 hour post PCI procedure3
Left ventricular ejection fraction (LVEF)
Time frame
Baseline, 1 month, 6 months and 12 months4
A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Time frame
1 month, 6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov