Clinical trial NCT04571580: Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention
Official title: Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute ST-segment Elevation Myocardial Infarction
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial infarct size
timeFrame: from days 2 through 7 after enrollment
Secondary outcomes:
measure: Amount of microvascular obstruction
timeFrame: from days 2 through 7 after enrollment
measure: ST-segment resolution
timeFrame: 60 minutes after reperfusion
measure: CKMB level
timeFrame: immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
measure: Left ventricular ejection fraction
timeFrame: 1 and 30 days after PCI
measure: Incidence of major adverse cardiac events (MACE)
timeFrame: 30 days after PCI
measure: Myocardial Blush Grade
timeFrame: 0-1 hour at the end of PCI
measure: TIMI corrected frame count
timeFrame: 0-1 hour at the end of PCI
measure: TIMI flow grade
timeFrame: 0-1 hour at the end of PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Zhongshan Hospital
name: Junbo Ge
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.