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

NCT01930682 | Completed Phase 4 DMC

• 2 other identifiers: BI135.32612410708300
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute ST-segment Elevation Myocardial Infarction

Keywords

Myocardial Infarction; Catheterization; Fibrinolysis

Outcome Measures

Primary Outcomes (1)

• Complete Epicardial and myocardial reperfusion;

  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 Outcomes (7)

• TIMI Flow Grade (TFG)

  Immediately after PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  Immediately after PCI

• ST-segment Resolution

  Immediately after PCI

• TIMI Frame Count (CTFC)

  Immediately after PCI

• TIMI Myocardial Perfusion Frame Count (TMPFC)

  Immediately after PCI

Other Outcomes (2)

• Main Safety Endpoints-Bleeding events

  30 days after randomization

• Left Ventricular Function

  in-hospital and 30 day

Study Arms (2)

Early post-fibrinolytic catheterisation

EXPERIMENTAL

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; Procedure: Early post-fibrinolytic catheterisation

Primary PCI

OTHER

For STEMI Patients,primary PCI is performed without fibrinolytic therapy.

Procedure: Primary PCI

Interventions

Alteplase DRUG

Alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.

Also known as: rt-PA

Early post-fibrinolytic catheterisation

Early post-fibrinolytic catheterisation PROCEDURE

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).

Early post-fibrinolytic catheterisation

Primary PCI PROCEDURE

For STEMI Patients,primary PCI is performed within 12 hours after the onset.

Primary PCI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (7)

• Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available.

  PMID: 18191746 BACKGROUND

• Gibson CM. Primary angioplasty compared with thrombolysis: new issues in the era of glycoprotein IIb/IIIa inhibition and intracoronary stenting. Ann Intern Med. 1999 May 18;130(10):841-7. doi: 10.7326/0003-4819-130-10-199905180-00019.

  PMID: 10366375 BACKGROUND

• Borgia F, Goodman SG, Halvorsen S, Cantor WJ, Piscione F, Le May MR, Fernandez-Aviles F, Sanchez PL, Dimopoulos K, Scheller B, Armstrong PW, Di Mario C. Early routine percutaneous coronary intervention after fibrinolysis vs. standard therapy in ST-segment elevation myocardial infarction: a meta-analysis. Eur Heart J. 2010 Sep;31(17):2156-69. doi: 10.1093/eurheartj/ehq204. Epub 2010 Jul 2.

  PMID: 20601393 BACKGROUND

• Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

  PMID: 19004841 BACKGROUND

• Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298.

  PMID: 19960517 BACKGROUND

• Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL; GRACIA-2 (Groupo de Analisis de Cardiopatia Isquemica Aguda) Investigators. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007 Apr;28(8):949-60. doi: 10.1093/eurheartj/ehl461. Epub 2007 Jan 23.

  PMID: 17244641 BACKGROUND

• Pu J, Ding S, Ge H, Han Y, Guo J, Lin R, Su X, Zhang H, Chen L, He B; EARLY-MYO Investigators. Efficacy and Safety of a Pharmaco-Invasive Strategy With Half-Dose Alteplase Versus Primary Angioplasty in ST-Segment-Elevation Myocardial Infarction: EARLY-MYO Trial (Early Routine Catheterization After Alteplase Fibrinolysis Versus Primary PCI in Acute ST-Segment-Elevation Myocardial Infarction). Circulation. 2017 Oct 17;136(16):1462-1473. doi: 10.1161/CIRCULATIONAHA.117.030582. Epub 2017 Aug 27.

  PMID: 28844990 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Ben He, MD

  RenJi Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 29, 2013
• Study Start: January 13, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 12, 2016
• Last Updated: August 29, 2017

Record last verified: 2013-08

Locations

CN (1)