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Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmacoinvasive strategy
Reduced-dose facilitated PCI strategy
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST-elevation myocardial infarction, primary percutaneous coronary, pharmacoinvasive strategy, reduced-dose fibrinolysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 or over and less than 75 years old;
  • Patents with STEMI with symptom onset persisted more than 30mim and within 6 h before randomization;
  • ECG >=2 mm ST-segment elevation in 2 contiguous precordial leads or >=1 mm ST- segment elevation in 2 contiguous extremity leads, or new left bundle branch block;
  • Patents with an expected time from FMC to PCI >=120 min.
  • Signed informed consent form prior to trial participation.

Exclusion Criteria:

  • Fibrinolysis contradictions: Definite hemorrhagic stroke history;ischemic stroke or cerebrovascular accident in nearly 6 months;
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months);
  • Active bleeding or known bleeding disorder/diathesis; Recent administration of any i.v. or s.c. anticoagulation within 12 hours including unfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation (warfarin or coumadin);
  • Arterial aneurysm, arterial/venous malformation and aorta dissection; Uncontrolled hypertension, defined as a single blood pressure measurement >=180/110 mm Hg (systolic BP >=180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation;
  • Major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction);
  • prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days. 2. Complex heart condition Evidence of cardiac rupture; Pre-existing heart failure and previous New York heart function classification III-IVCardiogenic shock (SBP <90mmHg after fluid infusion or SBP<100mmHg after vasoactive drugs);
  • PCI within previous 1 month or previous bypass surgery;
  • Myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization;
  • Known acute pericarditis and/or subacute bacterial endocarditis;
  • Hospitalization for cardiac reason within past 48 hours;
  • Severe comorbidity: Other diseases with life expectancy <=12 months;
  • Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis);
  • neutropenia, thrombocytopenia;
  • Severe COPD with hypoxemia;
  • Not suitable for clinical trial: Inclusion in another clinical trial; Previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
  • Pregnant or lactating;
  • Body weight <40kg;
  • Known hypersensitivity to any drug that may be used in the study;
  • Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

    Pharmacoinvasive strategy, fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early invasive strategy (in case of successful fibrinolysis)

    Reduced-dose fibrinolysis combined with immediate invasive therapy

    Outcomes

    Primary Outcome Measures

    The rate of major composite endpoint events
    Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock

    Secondary Outcome Measures

    The rate of major ventricular arrhythmia
    Ventricular arrhythmias, occurring more than 6 hours after randomization, persisting for at least 30 seconds, and accompanying with unstable hemodynamics that required electrical cardioversion / defibrillation
    The rate of ischemia stroke
    Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as a computerized tomography (CT) or magnetic resonance imaging (MRI) be performed.
    The rate of death
    Death will be classified as cardiovascular or non-cardiovascular.
    The rate of reinfarction
    Recurrent symptoms or signs of cardiac ischemia lasting more than 30 minutes with new ST-T segment changes or Q-wave in at least 2 contiguous leads or new onset LBBB and recurrent significant increase in cardiac enzyme levels. The increase in CK-MB level is considered significant when it occurs after at least a ≥25% decrease in CK-MB from a prior peak level and is >2 times the upper limit of normal (ULN) in the absence of coronary interventions, or >5 times above the ULN after PCI
    The rate of stent thrombosis
    The stent thrombosis are defined in accordance with the Academic Research Consortium (ARC) definitions
    The rate of target vessel revascularization
    The target vessel revascularizationare defined in accordance with the Academic Research Consortium (ARC) definitions
    The rate of congestive heart failure
    New or worsening congestive heart failure will be considered as patients presenting with at least one of the following conditions and requiring treatment with diuretics: 1) Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause; 2) Rales >1/3 up from the lung base; 3) Pulmonary capillary wedge pressure (PCWP) >25 mmHg; 4) Dyspnea with PO2 < 80 mmHg or O2 sat < 90 % (no supplemental O2) in the absence of known lung disease.
    The rate of Cardiogenic shock
    The manifestation of vascular collapse and shock (systolic BP < 90 mmHg for at least 30 min or systolic BP > 90 mmHg after inotropic or intra-aortic balloon support with a cardiac index < 2.2 L/min/m2 or < 2.5 L/min/m2 after inotropic or intra-aortic balloon support, peripheral signs of hypoperfusion, and chest X-ray with pulmonary edema
    Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion
    TIMI flow grade (TFG) 3 for epicardial reperfusion
    Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
    TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
    Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
    Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
    Peak CK-MB level
    Peak CK-MB level
    Adverse events
    Intracranial bleeding or major bleeding

    Full Information

    First Posted
    February 9, 2021
    Last Updated
    February 10, 2021
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04752345
    Brief Title
    Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay
    Official Title
    A Prospective Randomized Multi-center Clinical Trial Comparing Different Fibrinolysis-transfer Percutaneous Coronary Intervention Strategies in Acute ST-segment Elevation Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay
    Detailed Description
    OPTIMAL-REPERFUSION is an investigator-initiated, prospective, multicenter, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of medical contact to percutaneous coronary intervention ≥120 min will be randomized to a reduced-dose facilitated PCI strategy (reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours) or to pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST Elevation Myocardial Infarction
    Keywords
    ST-elevation myocardial infarction, primary percutaneous coronary, pharmacoinvasive strategy, reduced-dose fibrinolysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    632 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Pharmacoinvasive strategy, fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early invasive strategy (in case of successful fibrinolysis)
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Reduced-dose fibrinolysis combined with immediate invasive therapy
    Intervention Type
    Other
    Intervention Name(s)
    Pharmacoinvasive strategy
    Intervention Description
    Pharmacoinvasive treatment [full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolysis)
    Intervention Type
    Other
    Intervention Name(s)
    Reduced-dose facilitated PCI strategy
    Intervention Description
    Reduced-dose facilitated PCI[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(<3 hours)]
    Primary Outcome Measure Information:
    Title
    The rate of major composite endpoint events
    Description
    Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    The rate of major ventricular arrhythmia
    Description
    Ventricular arrhythmias, occurring more than 6 hours after randomization, persisting for at least 30 seconds, and accompanying with unstable hemodynamics that required electrical cardioversion / defibrillation
    Time Frame
    1 year
    Title
    The rate of ischemia stroke
    Description
    Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as a computerized tomography (CT) or magnetic resonance imaging (MRI) be performed.
    Time Frame
    1 year
    Title
    The rate of death
    Description
    Death will be classified as cardiovascular or non-cardiovascular.
    Time Frame
    1 year
    Title
    The rate of reinfarction
    Description
    Recurrent symptoms or signs of cardiac ischemia lasting more than 30 minutes with new ST-T segment changes or Q-wave in at least 2 contiguous leads or new onset LBBB and recurrent significant increase in cardiac enzyme levels. The increase in CK-MB level is considered significant when it occurs after at least a ≥25% decrease in CK-MB from a prior peak level and is >2 times the upper limit of normal (ULN) in the absence of coronary interventions, or >5 times above the ULN after PCI
    Time Frame
    1 year
    Title
    The rate of stent thrombosis
    Description
    The stent thrombosis are defined in accordance with the Academic Research Consortium (ARC) definitions
    Time Frame
    1 year
    Title
    The rate of target vessel revascularization
    Description
    The target vessel revascularizationare defined in accordance with the Academic Research Consortium (ARC) definitions
    Time Frame
    1year
    Title
    The rate of congestive heart failure
    Description
    New or worsening congestive heart failure will be considered as patients presenting with at least one of the following conditions and requiring treatment with diuretics: 1) Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause; 2) Rales >1/3 up from the lung base; 3) Pulmonary capillary wedge pressure (PCWP) >25 mmHg; 4) Dyspnea with PO2 < 80 mmHg or O2 sat < 90 % (no supplemental O2) in the absence of known lung disease.
    Time Frame
    1 year
    Title
    The rate of Cardiogenic shock
    Description
    The manifestation of vascular collapse and shock (systolic BP < 90 mmHg for at least 30 min or systolic BP > 90 mmHg after inotropic or intra-aortic balloon support with a cardiac index < 2.2 L/min/m2 or < 2.5 L/min/m2 after inotropic or intra-aortic balloon support, peripheral signs of hypoperfusion, and chest X-ray with pulmonary edema
    Time Frame
    1 year
    Title
    Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion
    Description
    TIMI flow grade (TFG) 3 for epicardial reperfusion
    Time Frame
    1 minute after stent was deployed
    Title
    Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
    Description
    TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
    Time Frame
    1 minute after stent was deployed
    Title
    Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
    Description
    Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
    Time Frame
    60min after the stent was deployed
    Title
    Peak CK-MB level
    Description
    Peak CK-MB level
    Time Frame
    48 hours after system onset
    Title
    Adverse events
    Description
    Intracranial bleeding or major bleeding
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Cost-effectiveness of reduced-dose pharmacoinvasive strategy compared to current care
    Description
    The total costs during the first 12 months include resources used during the first hospitalization including transportation and catheterization procedures, medications, examinations, management of complications and subsequent hospital admissions for cardiovascular problems in the first year after STEMI
    Time Frame
    1 year
    Title
    Health-related quality of life
    Description
    Measured with EQ-5D questionnaire
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 or over and less than 75 years old; Patents with STEMI with symptom onset persisted more than 30mim and within 6 h before randomization; ECG >=2 mm ST-segment elevation in 2 contiguous precordial leads or >=1 mm ST- segment elevation in 2 contiguous extremity leads, or new left bundle branch block; Patents with an expected time from FMC to PCI >=120 min. Signed informed consent form prior to trial participation. Exclusion Criteria: Fibrinolysis contradictions: Definite hemorrhagic stroke history;ischemic stroke or cerebrovascular accident in nearly 6 months; Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months); Active bleeding or known bleeding disorder/diathesis; Recent administration of any i.v. or s.c. anticoagulation within 12 hours including unfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation (warfarin or coumadin); Arterial aneurysm, arterial/venous malformation and aorta dissection; Uncontrolled hypertension, defined as a single blood pressure measurement >=180/110 mm Hg (systolic BP >=180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation; Major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days. 2. Complex heart condition Evidence of cardiac rupture; Pre-existing heart failure and previous New York heart function classification III-IVCardiogenic shock (SBP <90mmHg after fluid infusion or SBP<100mmHg after vasoactive drugs); PCI within previous 1 month or previous bypass surgery; Myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization; Known acute pericarditis and/or subacute bacterial endocarditis; Hospitalization for cardiac reason within past 48 hours; Severe comorbidity: Other diseases with life expectancy <=12 months; Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia, thrombocytopenia; Severe COPD with hypoxemia; Not suitable for clinical trial: Inclusion in another clinical trial; Previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days; Pregnant or lactating; Body weight <40kg; Known hypersensitivity to any drug that may be used in the study; Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong He
    Phone
    +86 13981919366
    Email
    heyong_huaxi@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhongxiu Chen
    Phone
    +86 18030708238
    Email
    619087296@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong He
    Organizational Affiliation
    Department of Cardiology, West China Hospital of Sichuan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD will be shared within six months after the trial finished through Electronic data capture system or ResMan
    IPD Sharing Time Frame
    Within six months after the trial complete
    Citations:
    PubMed Identifier
    33634478
    Citation
    Chen Z, Wang D, Ma M, Li C, Wan Z, Zhang L, Zhu Y, Wang M, Wang H, He S, Peng Y, Wei J, Huang B, He Y; OPTIMAL-REPERFUSION trial investigator. Rationale and design of the OPTIMAL-REPERFUSION trial: A prospective randomized multi-center clinical trial comparing different fibrinolysis-transfer percutaneous coronary intervention strategies in acute ST-segment elevation myocardial infarction. Clin Cardiol. 2021 Apr;44(4):455-462. doi: 10.1002/clc.23582. Epub 2021 Feb 25.
    Results Reference
    derived

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    Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

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