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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
intracoronary infusion with normal saline
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
Department of Cardiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Myocardial infarct size
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)
Time frame: from days 2 through 7 after enrollment
Amount of microvascular obstruction
The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI
Time frame: from days 2 through 7 after enrollment
ST-segment resolution
The percentage ST-segment resolution on an electrocardiogram
Time frame: 60 minutes after reperfusion
CKMB level
CKMB area under the curve (AUC)
Time frame: immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
Left ventricular ejection fraction
Left ventricular ejection fraction assessed by echocardiography
Time frame: 1 and 30 days after PCI
Incidence of major adverse cardiac events (MACE)
The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization
Time frame: 30 days after PCI
Myocardial Blush Grade
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of myocardial blush
Time frame: 0-1 hour at the end of PCI
TIMI corrected frame count
Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion
Time frame: 0-1 hour at the end of PCI
TIMI flow grade
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of coronary flow
Time frame: 0-1 hour at the end of PCI
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