EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction (EARLY-MYO)

August 28, 2017 updated by: RenJi Hospital

EARLY Routine Catheterization or Rescue Angioplasty After Alteplase Fibrinolysis vs. Primary Angioplasty in Acute ST-elevation MYOcardial Infarction: An Open, Prospective, Randomized, Multicentre Trial

The EARLY-MYO (EARLY routine catheterization after alteplase fibrinolysis vs. primary PCI in acute ST-segment elevation MYOcardial infarction) is an investigator-initiated, prospective, multicenter, randomized (1:1), open-label, actively-controlled, parallel group, non-inferiority trial comparing the efficacy and safety of a PhI strategy with half-dose fibrinolysis versus PPCI in STEMI patients presenting within 6 hours after symptom onset and with an expected PCI-related delay of ≥60 min.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early, successful restoration of myocardial perfusion after a ST-elevation myocardial infarction (STEMI) is the most effective way to reduce final infarct size and improve clinical outcome. Reperfusion for STEMI treatment in the modern era encompasses mechanical and pharmacological strategies. It is generally well-accepted that primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for all STEMI patients when it can be performed within the guideline-recommended timeframe at PPCI-capable facilities. However, PPCI is not universally available, and delays in performing percutaneous coronary intervention (PCI) are common in real-world practice. Even in some large cities, patients have a high chance of presenting to hospitals not providing around-the-clock PPCI service. Given this background, in recent years there has been great interest and progress in creating triage strategies for STEMI patients who cannot receive timely PPCI.

Pharmaco-invasive (PhI) strategy, an early reperfusion strategy by initial prompt fibrinolysis with subsequent early catheterization (with either routine early PCI after successful fibrinolysis or rescue PCI as needed), has been proposed as a therapeutic option for STEMI patients when timely PPCI is not feasible. However, current evidence on the efficacy and safety of PhI strategy in STEMI patients is limited, and the role of PhI strategy in STEMI continues to be debated. Given that no randomized clinical trial is available to compare a PhI strategy with half-dose fibrinolytic regimen versus PPCI in STEMI patients, investigators plan to perform a controlled, randomized trial to evaluate the efficacy and safety of a PhI strategy with half-dose alteplase fibrinolysis versus PPCI in STEMI patients.

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • RenJi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: over 18 or 18 years old, less than 75 years old;
  • Patents with myocardial infarction who have symptom onset within 6h before randomization;
  • ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
  • Patents with an expected PCI-related delay [expected time delay from FMC to first balloon dilation≥90 min, and difference between the time of FMC to balloon dilation minus the time from FMC to start of fibrinolysis ≥60 minutes)];
  • Signed informed consent form prior to trial participation.

Exclusion Criteria:

  1. Evidence of cardiac rupture;
  2. ECG: new left bundle branch block;
  3. "Diagnosis to balloon inflation" time over 3 hours;

  4. Thrombolysis contradictions:

    • Definite cerebral apoplexy history;
    • 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);
    • 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, 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;

  5. Severe complication

    • Other diseases with life expectancy ≤12 months;
    • Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis;
    • Known acute pericarditis and/or subacute bacterial endocarditis;
    • Arterial aneurysm, arterial/venous malformation and aorta dissection;

  6. Complex heart condition

    • Cardiogenic shock(SBP <90 mmHg after fluid infusion or SBP<100 mmHg after vasoactive drugs);
    • PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);
    • Previously known multivessel coronary artery disease not suitable for revascularization;
    • Hospitalisation for cardiac reason within past 48 hours;

  7. Not suitable for clinical trial

    • Inclusion in another clinical trial;
    • Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
    • Pregnancy or lactating;
    • Body weight <40kg or >125kg;
    • Known hypersensitivity to any drug that may appear in the study;
    • Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early post-fibrinolytic catheterisation
For STEMI Patients, alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.Early routine catheterization after 3 hours but within 24 hours of the start of fibrinolytic therapy is performed, if required, PCI or, in case of insufficient ST resolution at 90 min,rescue PCI. The decision on rescue PCI will, however, be taken 90 min (or earlier if clinically indicated) after injection of alteplase according to the ST resolution (less than 50% reduction in ST-segment elevation).
Drug: Alteplase
Alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.
Other Names:
  • rt-PA
Procedure: Early post-fibrinolytic catheterisation
Early post-fibrinolytic catheterisation after 3 hours but within 24 hours of the start of fibrinolytic therapy is performed, if required, PCI or, in case of insufficient ST resolution at 90 min,rescue PCI. The decision on rescue PCI will, however, be taken 90 min (or earlier if clinically indicated) after injection of alteplase according to the ST resolution (less than 50% reduction in ST-segment elevation).
Other: Primary PCI
For STEMI Patients,primary PCI is performed without fibrinolytic therapy.
Procedure: Primary PCI
For STEMI Patients,primary PCI is performed within 12 hours after the onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Epicardial and myocardial reperfusion;
Time Frame: Immediately after PCI
defined as TIMI Flow Grade 3 (TFG 3) for epicardial reperfusion and TIMI Myocardial Perfusion Grade 3 (TMPG 3) for myocardial reperfusionand resolution of the initial sum of ST-segment elevation ≥ 70% in 60 min post catheterisation
Immediately after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI Flow Grade (TFG)
Time Frame: Immediately after PCI
TIMI Flow Grade (TFG) assesses flow in the epicardial arteries.
Immediately after PCI
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame: Immediately after PCI
TMPG is an angiographic measure of myocardial perfusion.
Immediately after PCI
ST-segment Resolution
Time Frame: Immediately after PCI
Resolution of the initial sum of ST-segment elevation ≥ 70%.
Immediately after PCI
TIMI Frame Count (CTFC)
Time Frame: Immediately after PCI
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Immediately after PCI
TIMI Myocardial Perfusion Frame Count (TMPFC)
Time Frame: Immediately after PCI
TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec.
Immediately after PCI
Wall motion score index (WMSI) by echocardiography
Time Frame: in-hospital and 30 day
The WMSI will be calculated as the sum of the scores in each segment divided by 16. Each segment will be given a score based on its systolic function (normal = 1, hypokinesis = 2, akinesis = 3).
in-hospital and 30 day
Clinical Outcomes
Time Frame: 30 days after randomization
All cause death, non-fatal reinfarction, heart failure, and stroke after randomization constitute the clinical endpoints.
30 days after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Safety Endpoints-Bleeding events
Time Frame: 30 days after randomization
Incidence of bleeding events, classified by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) severity criteria
30 days after randomization
Left Ventricular Function
Time Frame: in-hospital and 30 day
Left ventricular function assessment by echocardiography and cardiac magnetic resonance
in-hospital and 30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Director: Ben He, MD, RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 12, 2016

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 25, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI135.326
  • 12410708300 (Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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