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

NCT04571580 | Terminated Phase 3

• 1 other identifier: RECOVERII
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Amount of microvascular obstruction

  from days 2 through 7 after enrollment

• ST-segment resolution

  60 minutes after reperfusion

• CKMB level

  immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours

• Left ventricular ejection fraction

  1 and 30 days after PCI

• Incidence of major adverse cardiac events (MACE)

  30 days after PCI

Study Arms (3)

placebo

PLACEBO COMPARATOR

intracoronary infusion with saline

Drug: Normal Saline

reteplase 9mg

EXPERIMENTAL

intracoronary infusion with reteplase 9mg

Drug: Reteplase Injection 9mg

reteplase 18mg

EXPERIMENTAL

intracoronary infusion with reteplase 18mg

Drug: Reteplase Injection 18mg

Interventions

Normal Saline DRUG

intracoronary infusion with normal saline

Also known as: intracoronary normal saline

placebo

Reteplase Injection 9mg DRUG

low-dose intracoronary fibrinolytic therapy with reteplase 9mg

Also known as: intracoronary reteplase 9mg

reteplase 9mg

Reteplase Injection 18mg DRUG

low-dose intracoronary fibrinolytic therapy with reteplase 18mg

Also known as: intracoronary reteplase 18mg

reteplase 18mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Rescue PCI after thrombolytic therapy.
• Need for emergency coronary artery bypass grafting.
• Presence of cardiogenic shock.
• Life expectancy of \< 6 months.
• Inability to provide informed consent.
• 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.

Sponsors & Collaborators

• Ge Junbo: lead

Study Sites (1)

Department of Cardiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related 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. Cardiovasc Diagn Ther. 2022 Jun;12(3):352-359. doi: 10.21037/cdt-21-756.

  PMID: 35800360 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Saline Solution; reteplase

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Junbo Ge

  Department of Cardiology, Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Dept. of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: October 1, 2020
• Study Start: July 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

CN (1)