Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
Overview
- Phase
- Phase 4
- Intervention
- Urokinase
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 100
- Primary Endpoint
- Outcomes at 30 days
- Last Updated
- 6 years ago
Overview
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
Investigators
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza
Eligibility Criteria
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
Arms & Interventions
Urokinase
Patients will be randomized to to receive local bolus of 200,000 units urokinase
Intervention: Urokinase
Saline
Patients will be randomized to to receive local bolus of intracoronary saline
Intervention: Saline
Outcomes
Primary Outcomes
Outcomes at 30 days
Time Frame: 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 Outcomes
- Left ventricular remodeling(Up to 1 year after Primary PCI)
- Myocardial reperfusion after Primary CI(Up to 90 minutes after Primary PCI)
- 5-year MACE(Up to 5 years after Primary PCI)