Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention

Acute ST-segment Elevation Myocardial Infarction Clinical Trial

— RECOVERII  

Official title:

Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04571580
• Other study ID #: RECOVERII
• Status: Terminated
• Phase: Phase 3
• Start date: July 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute ST-segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Normal Saline
intracoronary infusion with normal saline
• Reteplase Injection 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
• Reteplase Injection 18mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg

Locations

Country	Name	City	State
China	Department of Cardiology, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ge Junbo

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Cardiovas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size	Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)	from days 2 through 7 after enrollment
Secondary	Amount of microvascular obstruction	The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI	from days 2 through 7 after enrollment
Secondary	ST-segment resolution	The percentage ST-segment resolution on an electrocardiogram	60 minutes after reperfusion
Secondary	CKMB level	CKMB area under the curve (AUC)	immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
Secondary	Left ventricular ejection fraction	Left ventricular ejection fraction assessed by echocardiography	1 and 30 days after PCI
Secondary	Incidence of major adverse cardiac events (MACE)	The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization	30 days after PCI
Secondary	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	0-1 hour at the end of PCI
Secondary	TIMI corrected frame count	Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion	0-1 hour at the end of PCI
Secondary	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	0-1 hour at the end of PCI