Local Thrombolytics Before Thrombectomy in STEMI

Study Overview
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Brief Summary
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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
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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

Official Title
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Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Urokinase
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urokinase<br>Patients will be randomized to to receive local bolus of 200,000 units urokinase | Drug: Urokinase<br>* intracoronary, urokinase, 200,000 Units, bolus<br>* Other names: UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ;|
| Active Comparator: Saline<br>Patients will be randomized to to receive local bolus of intracoronary saline | Drug: Saline<br>* intracoronary, saline, bolus 1 cc<br>* Other names: Saline infusion;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombectomy