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
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
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
NCT ID
NCT04752345
First Posted
February 9, 2021
Last Updated
February 10, 2021
Sponsor
West China Hospital
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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