Local Thrombolytics Before Thrombectomy in STEMI
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Urokinase (Drug); Saline (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s): Cesare Greco, MD, Study Director, Affiliation: University Sapienza
Overall contact: Gaetano Tanzilli, MD, Phone: +39064997, Ext: 262, Email: gaetano.tanzilli@uniroma1.it
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.
Clinical Details
Official title: Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: MACE at 30 days
Secondary outcome: Myocardial reperfusion after Primary CI
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gaetano Tanzilli, MD, Phone: +39064997, Ext: 262, Email: gaetano.tanzilli@uniroma1.it Additional Information
Starting date: January 2014
Last updated: March 6, 2013
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