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DISSOLUTION: Local Thrombolytics Before Thrombectomy in STEMI

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Unknown status
CT.gov ID
NCT01568931
Collaborator
(none)
100
Enrollment
2
Arms
85.9
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Urokinase

Patients will be randomized to to receive local bolus of 200,000 units urokinase

Drug: Urokinase
intracoronary, urokinase, 200,000 Units, bolus
Other Names:
  • UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ

    		•
    Active Comparator: Saline

    Patients will be randomized to to receive local bolus of intracoronary saline

    Drug: Saline
    intracoronary, saline, bolus 1 cc
    Other Names:
  • Saline infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Outcomes at 30 days [Up to 30 days]

      30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis

    Secondary Outcome Measures

    1. Myocardial reperfusion after Primary CI [Up to 90 minutes after Primary PCI]

      ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI

    2. Left ventricular remodeling [Up to 1 year after Primary PCI]

      A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography

    3. 5-year MACE [Up to 5 years after Primary PCI]

      Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    • Study Director: Cesare Greco, MD, University Sapienza

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT01568931
    Other Study ID Numbers:
    • 197/2012/D
    First Posted:
    Apr 2, 2012
    Last Update Posted:
    Apr 8, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    thrombectomy
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Coal Tar

    Study Results

    No Results Posted as of Apr 8, 2020