Clinical trial NCT04752345: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: ST-elevation myocardial infarction
primary percutaneous coronary
pharmacoinvasive strategy
reduced-dose fibrinolysis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The rate of major composite endpoint events
timeFrame: 30 days
Secondary outcomes:
measure: The rate of major ventricular arrhythmia
timeFrame: 1 year
measure: The rate of ischemia stroke
timeFrame: 1 year
measure: The rate of death
timeFrame: 1 year
measure: The rate of reinfarction
timeFrame: 1 year
measure: The rate of stent thrombosis
timeFrame: 1 year
measure: The rate of target vessel revascularization
timeFrame: 1year
measure: The rate of congestive heart failure
timeFrame: 1 year
measure: The rate of Cardiogenic shock
timeFrame: 1 year
measure: Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion
timeFrame: 1 minute after stent was deployed
measure: Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
timeFrame: 1 minute after stent was deployed
measure: Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
timeFrame: 60min after the stent was deployed
measure: Peak CK-MB level
timeFrame: 48 hours after system onset
measure: Adverse events
timeFrame: 1 year
Other outcomes:
measure: Cost-effectiveness of reduced-dose pharmacoinvasive strategy compared to current care
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 year
Locations:
Study officials:
affiliation: Department of Cardiology, West China Hospital of Sichuan University
name: Yong He
role: PRINCIPAL_INVESTIGATOR
References:
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.