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

NCT04571580 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-09-14

No results posted yet for this study

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

Interventions

DRUG

Normal Saline

intracoronary infusion with normal saline

DRUG

Reteplase Injection 9mg

low-dose intracoronary fibrinolytic therapy with reteplase 9mg

DRUG

Reteplase Injection 18mg

low-dose intracoronary fibrinolytic therapy with reteplase 18mg

Sponsors & Collaborators

  • Ge Junbo

    lead OTHER

Principal Investigators

  • Junbo Ge · Department of Cardiology, Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571580 on ClinicalTrials.gov