Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2014-01-31
2021-03-31
Brief Summary
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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.
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Detailed Description
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Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Urokinase
Patients will be randomized to to receive local bolus of 200,000 units urokinase
Urokinase
intracoronary, urokinase, 200,000 Units, bolus
Saline
Patients will be randomized to to receive local bolus of intracoronary saline
Saline
intracoronary, saline, bolus 1 cc
Interventions
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Urokinase
intracoronary, urokinase, 200,000 Units, bolus
Saline
intracoronary, saline, bolus 1 cc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Pelliccia
Assistant Professor
Principal Investigators
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Cesare Greco, MD
Role: STUDY_DIRECTOR
University Sapienza
Other Identifiers
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197/2012/D
Identifier Type: -
Identifier Source: org_study_id
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