Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention
NCT ID: NCT04571580
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
36 participants
INTERVENTIONAL
2021-07-01
2023-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo
intracoronary infusion with saline
Normal Saline
intracoronary infusion with normal saline
reteplase 9mg
intracoronary infusion with reteplase 9mg
Reteplase Injection 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
reteplase 18mg
intracoronary infusion with reteplase 18mg
Reteplase Injection 18mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
Interventions
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Reteplase Injection 18mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
Normal Saline
intracoronary infusion with normal saline
Reteplase Injection 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Ge Junbo
OTHER
Responsible Party
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Ge Junbo
Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
Principal Investigators
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Junbo Ge
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Zhongshan Hospital
Locations
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Department of Cardiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Huang D, Ma Y, Wu H, Zhong X, Gao W, Zhou J, Qian J, Ge J. Impact of intracoronary reteplase during primary percutaneous coronary intervention on infarct size in large anterior myocardial infarction: rationale and design of the RECOVER II trial. Cardiovasc Diagn Ther. 2022 Jun;12(3):352-359. doi: 10.21037/cdt-21-756.
Other Identifiers
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RECOVERII
Identifier Type: -
Identifier Source: org_study_id
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