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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

Page last updated: August 23, 2015

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