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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary rhTNK-tPA | Experimental |
| |
| Intracoronary Tirofiban | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTNK-tPA, 4-8 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected TIMI frame count (CTFC) | At the end of Percutaneous Coronary Intervention procedure |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI flow grade | At the end of Percutaneous Coronary Intervention procedure | |
| Complete ST-segment resolution (STR) | 1 hour post PCI procedure | |
| Left ventricular ejection fraction (LVEF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Zhang | Contact | +86 37158681037 | 13598019682@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Tirofiban | Drug | Intracoronary influsion of Tirofiban (10 µg/kg) , and then administered intravenously at 0.075-0.15 µg/kg.min for 36 h or longer |
|
| Baseline, 1 month, 6 months and 12 months |
| A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure | 1 month, 6 months and 12 months |
| Bleeding events according to the BARC bleeding classification | At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000602 |
| Amino Acids, Peptides, and Proteins |