Local Thrombolytics Before Thrombectomy in STEMI

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Saline; Drug: Urokinase

• Registration Number: NCT01568931
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.

Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.

Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.

Detailed Description

The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).

Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Study Start: 2014-01
• Primary Completion: 2020-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ST-elevation myocardial infarction
• angiographic evidence of massive thrombosis in the culprit artery
• Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
• Able to understand and willing to sign the informed CF

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Exclusion Criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Patients will be randomized to to receive local bolus of intracoronary saline
Urokinase	Urokinase	Patients will be randomized to to receive local bolus of 200,000 units urokinase

Primary Outcome Measures

Name	Time	Method
Outcomes at 30 days	Up to 30 days	30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis

Secondary Outcome Measures

Name	Time	Method
Left ventricular remodeling	Up to 1 year after Primary PCI	A change in left ventricular end-diastolic volume\>20% (compared with baseline values) as assessed at 1-year echocardiography
Myocardial reperfusion after Primary CI	Up to 90 minutes after Primary PCI	ST-segment resolution (STR)\>70% as assessed 90 minutes after Primary PCI
5-year MACE	Up to 5 years after Primary PCI	Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure