Acute ST-segment Elevation Myocardial Infarction
Conditions
Brief summary
OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with reteplase infused after coronary reperfusion will reduce the myocardial infarction size. DESIGN, SETTING, AND PARTICIPANTS: 306 patients presenting at 15 hospitals in China within 12 hours of acute ST-segment elevation myocardial infarction (STEMI) due to a proximal-mid-vessel occlusion of left anterior descending (LAD) coronary artery occlusion will be randomized in a 1:1:1 dose-ranging trial design. Patients will be followed up to 1 month. INTERVENTIONS: Participants will be randomly assigned to treatment with placebo (n = 102), reteplase 9mg (n = 102), or reteplase 18mg (n = 102) by manual infusion over 2 minutes after reperfusion of the infarct-related coronary artery and before stent implant. MAIN OUTCOMES AND MEASURES The primary outcomewas the myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment.
Interventions
DRUGNormal Saline
intracoronary infusion with normal saline
DRUGReteplase Injection 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
DRUGReteplase Injection 18mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
Sponsors
Ge Junbo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Acute STEMI with persistent ST-segment elevation or recent left bundle-branch block with a symptom onset to reperfusion time of 12 hours or less. 2. Angiographic criteria included a proximal-mid coronary artery occlusion (TIMI coronary flow grade 0 or 1) or, impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of large thrombus (TIMI grade ≥2) in left anterior descending (LAD) coronary artery.
Exclusion criteria
1. Rescue PCI after thrombolytic therapy. 2. Need for emergency coronary artery bypass grafting. 3. Presence of cardiogenic shock. 4. Life expectancy of \< 6 months. 5. Inability to provide informed consent. 6. Contraindications for the use of thrombolysis, including active internal bleeding, history of intracranial haemorrhage or ischaemic stroke within 6 months, recent major surgery or trauma, severe uncontrolled hypertension, thrombocytopenia and severe liver or kidney failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarct size | from days 2 through 7 after enrollment | Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ST-segment resolution | 60 minutes after reperfusion | The percentage ST-segment resolution on an electrocardiogram |
| CKMB level | immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours | CKMB area under the curve (AUC) |
| Left ventricular ejection fraction | 1 and 30 days after PCI | Left ventricular ejection fraction assessed by echocardiography |
| Amount of microvascular obstruction | from days 2 through 7 after enrollment | The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI |
| Myocardial Blush Grade | 0-1 hour at the end of PCI | Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of myocardial blush |
| TIMI corrected frame count | 0-1 hour at the end of PCI | Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion |
| TIMI flow grade | 0-1 hour at the end of PCI | Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of coronary flow |
| Incidence of major adverse cardiac events (MACE) | 30 days after PCI | The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization |
Countries
China
Outcome results
None listed