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Local Thrombolytics Before Thrombectomy in STEMI (DISSOLUTION)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Urokinase
Saline
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Urokinase

    Saline

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Outcomes at 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

    Myocardial reperfusion after Primary CI
    ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
    Left ventricular remodeling
    A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography
    5-year MACE
    Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure

    Full Information

    First Posted
    March 29, 2012
    Last Updated
    April 6, 2020
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01568931
    Brief Title
    Local Thrombolytics Before Thrombectomy in STEMI
    Acronym
    DISSOLUTION
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    March 2020 (Actual)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    thrombectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Urokinase
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomized to to receive local bolus of 200,000 units urokinase
    Arm Title
    Saline
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomized to to receive local bolus of intracoronary saline
    Intervention Type
    Drug
    Intervention Name(s)
    Urokinase
    Other Intervention Name(s)
    UROKINASE-R, IMARX THERAPEUTICS INC., Tucson, AZ
    Intervention Description
    intracoronary, urokinase, 200,000 Units, bolus
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    Saline infusion
    Intervention Description
    intracoronary, saline, bolus 1 cc
    Primary Outcome Measure Information:
    Title
    Outcomes at 30 days
    Description
    30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
    Time Frame
    Up to 30 days
    Secondary Outcome Measure Information:
    Title
    Myocardial reperfusion after Primary CI
    Description
    ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI
    Time Frame
    Up to 90 minutes after Primary PCI
    Title
    Left ventricular remodeling
    Description
    A change in left ventricular end-diastolic volume>20% (compared with baseline values) as assessed at 1-year echocardiography
    Time Frame
    Up to 1 year after Primary PCI
    Title
    5-year MACE
    Description
    Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
    Time Frame
    Up to 5 years after Primary PCI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cesare Greco, MD
    Organizational Affiliation
    University Sapienza
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Local Thrombolytics Before Thrombectomy in STEMI

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