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Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction (UFH-STEMI)

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Unfractionated heparin
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring Myocardial Reperfusion, Unfractionated heparin, pre-treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients with STEMI referred for primary PCI
  • Duration of symptoms less than 6 hours before presentation

Exclusion Criteria:

  • Pregnancy
  • Cardiogenic shock at presentation (hemodynamic instability)
  • Cardiac arrest before randomization
  • Duration of symptoms for more than 6 hours before presentation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Early unfractionated heparin

    Control - Unfractionated heparin for coronary intervention only

    Arm Description

    Administration of UFH at a dose of 100 IU/kg body weight at first medical contact. Addition of UFH before coronary intervention according to ACT measurement after coronary angiography before coronary intervention.

    Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention.

    Outcomes

    Primary Outcome Measures

    TIMI flow
    TIMI flow in culprit coronary artery at first coronary angiography

    Secondary Outcome Measures

    Bleeding
    Bleeding assessed by Bleeding Academic Research Consortium (BARC) score. BARC incorporates 5 bleeding types, ranging from BARC 0 - no bleeding to BARC 5 - fatal bleeding.
    Cardiogenic shock
    Presence of cardiogenic shock at any time after randomization
    30 day mortality after STEMI
    30-day mortality after STEMI
    Troponin I concentration 24 h after primary PCI
    Troponin I concentration 24 h after primary PCI

    Full Information

    First Posted
    January 30, 2022
    Last Updated
    February 9, 2022
    Sponsor
    University Medical Centre Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05247424
    Brief Title
    Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
    Acronym
    UFH-STEMI
    Official Title
    Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention. Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.
    Detailed Description
    Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight. The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality. Investigators plan to randomize 600 patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    STEMI - ST Elevation Myocardial Infarction
    Keywords
    Myocardial Reperfusion, Unfractionated heparin, pre-treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomization in 1:1 ratio
    Masking
    Outcomes Assessor
    Masking Description
    Interventional cardiologists evaluating coronary angiography will be blinded to assigned group
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early unfractionated heparin
    Arm Type
    Experimental
    Arm Description
    Administration of UFH at a dose of 100 IU/kg body weight at first medical contact. Addition of UFH before coronary intervention according to ACT measurement after coronary angiography before coronary intervention.
    Arm Title
    Control - Unfractionated heparin for coronary intervention only
    Arm Type
    No Intervention
    Arm Description
    Control arm with administration of UFH at a dose of 100 IU/kg body weight after coronary angiography before coronary intervention.
    Intervention Type
    Drug
    Intervention Name(s)
    Unfractionated heparin
    Intervention Description
    Unfractionated heparin at dose of 100 IU /kg body weight
    Primary Outcome Measure Information:
    Title
    TIMI flow
    Description
    TIMI flow in culprit coronary artery at first coronary angiography
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Bleeding
    Description
    Bleeding assessed by Bleeding Academic Research Consortium (BARC) score. BARC incorporates 5 bleeding types, ranging from BARC 0 - no bleeding to BARC 5 - fatal bleeding.
    Time Frame
    Day 0
    Title
    Cardiogenic shock
    Description
    Presence of cardiogenic shock at any time after randomization
    Time Frame
    Day 0 to 10
    Title
    30 day mortality after STEMI
    Description
    30-day mortality after STEMI
    Time Frame
    30 days
    Title
    Troponin I concentration 24 h after primary PCI
    Description
    Troponin I concentration 24 h after primary PCI
    Time Frame
    24 h

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with STEMI referred for primary PCI Duration of symptoms less than 6 hours before presentation Exclusion Criteria: Pregnancy Cardiogenic shock at presentation (hemodynamic instability) Cardiac arrest before randomization Duration of symptoms for more than 6 hours before presentation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miša Fister, MD, PhD
    Phone
    +38615229825
    Email
    misa.fister@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tomaz Goslar, MD, PhD
    Phone
    +38615229825
    Email
    tomaz.goslar@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miša Fister, MD, PhD
    Organizational Affiliation
    UMC Ljubljana
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction

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