Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial|
- MACE at 30 days [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]30-day Major adverse cardiac events (MACE), defined as the occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
- Myocardial reperfusion after Primary CI [ Time Frame: Up to 90 minutes after Primary PCI ] [ Designated as safety issue: No ]ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Urokinase
Patients will be randomized to to receive local bolus of 200,000 units urokinase
intracoronary, urokinase, 200,000 Units, bolus
Other Name: UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
Active Comparator: Saline
Patients will be randomized to to receive local bolus of intracoronary saline
intracoronary, saline, bolus 1 cc
Other Name: Saline infusion
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568931
|Contact: Gaetano Tanzilli, MD||+39064997 ext firstname.lastname@example.org|
|Contact: Francesco Pelliccia, MD||+39064997 ext email@example.com|
|Study Director:||Cesare Greco, MD||University Sapienza|