Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

NCT ID: NCT04752345

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 632 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2023-09-30

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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Pharmacoinvasive strategy

Intervention Type: OTHER

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)

Experimental group

Reduced-dose fibrinolysis combined with immediate invasive therapy

Group Type: EXPERIMENTAL

Reduced-dose facilitated PCI strategy

Intervention Type: OTHER

Reduced-dose facilitated PCI\[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(\<3 hours)\]

Interventions

Pharmacoinvasive strategy

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

Reduced-dose facilitated PCI strategy

Reduced-dose facilitated PCI\[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(\<3 hours)\]

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong He

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, West China Hospital of Sichuan University

Central Contacts

Yong He

Role: CONTACT

heyong_huaxi@163.com

+86 13981919366

Zhongxiu Chen

Role: CONTACT

619087296@qq.com

+86 18030708238

References

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.

Reference Type: DERIVED

PMID: 33634478 (View on PubMed)

Other Identifiers

WestChinaH-CVD-002

Identifier Type: -

Identifier Source: org_study_id