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Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01568931
First received: March 29, 2012
Last updated: March 6, 2013
Last verified: March 2013

March 29, 2012
March 6, 2013
January 2014
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01568931 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Local Thrombolytics Before Thrombectomy in STEMI
Local Delivery of thrombolytIcs Before Thrombectomy in patientS With ST-elevatiOn myocardiaL Infarction Undergoing Primary percuTaneous Coronary interventION - The DISSOLUTION Randomized Trial

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Urokinase
    intracoronary, urokinase, 200,000 Units, bolus
    Other Name: UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
  • Drug: Saline
    intracoronary, saline, bolus 1 cc
    Other Name: Saline infusion
  • Active Comparator: Urokinase
    Patients will be randomized to to receive local bolus of 200,000 units urokinase
    Intervention: Drug: Urokinase
  • Active Comparator: Saline
    Patients will be randomized to to receive local bolus of intracoronary saline
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
March 2017
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gaetano Tanzilli, MD +39064997 ext 262 gaetano.tanzilli@uniroma1.it
Contact: Francesco Pelliccia, MD +39064997 ext 262 f.pelliccia@mclink.it
Not Provided
 
NCT01568931
197/2012/D
No
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Study Director: Cesare Greco, MD University Sapienza
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP