Acute ST-segment Elevation Myocardial InfarctionPhase 4EARLY-MYONCT01930682
EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction
A Phase 4 study testing Alteplase, Early post-fibrinolytic catheterisation and Primary PCI in people with Acute ST-segment Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute ST-segment Elevation Myocardial Infarction
- What is being tested?
- Alteplase, Early post-fibrinolytic catheterisation and Primary PCI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2014to 12 Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
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- 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.
Who cannot join
- 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);
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- 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;
- 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;
- Not suitable for clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Alteplase, Early post-fibrinolytic catheterisation, Primary PCI
- Keywords
- Myocardial Infarction, Catheterization, Fibrinolysis
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called rt-PA
Alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.
Early post-fibrinolytic catheterisationProcedure or surgery
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).
Primary PCIProcedure or surgery
For STEMI Patients,primary PCI is performed within 12 hours after the onset.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Alteplase; Procedure: Early post-fibrinolytic catheterisation |
| Primary PCI | Other | For STEMI Patients,primary PCI is performed without fibrinolytic therapy. Receives: Procedure: Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after PCI
Secondary outcomes (7)
TIMI Flow Grade (TFG)
TIMI Flow Grade (TFG) assesses flow in the epicardial arteries.
Measured: Immediately after PCI
TIMI Myocardial Perfusion Grade (TMPG)
TMPG is an angiographic measure of myocardial perfusion.
Measured: Immediately after PCI
ST-segment Resolution
Resolution of the initial sum of ST-segment elevation ≥ 70%.
Measured: Immediately after PCI
TIMI Frame Count (CTFC)
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Measured: Immediately after PCI
TIMI Myocardial Perfusion Frame Count (TMPFC)
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.
Measured: Immediately after PCI
Wall motion score index (WMSI) by echocardiography
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).
Measured: in-hospital and 30 day
Clinical Outcomes
All cause death, non-fatal reinfarction, heart failure, and stroke after randomization constitute the clinical endpoints.
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start13 Jan 2014
- Primary completionSep 2016
- Study completion12 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben He, MD, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930682
- Sponsor's protocol ID
- BI135.326
- Other IDs
- 12410708300
- Acronym
- EARLY-MYO
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18191746Gibson 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.
PubMed 10366375Borgia 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.
PubMed 20601393Van 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.
PubMed 19004841Ding 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.
PubMed 19960517Fernandez-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.
PubMed 17244641Pu 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.
PubMed 28844990
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY Routine Catheterization or Rescue Angioplasty After Alteplase Fibrinolysis vs. Primary Angioplasty in Acute ST-elevation MYOcardial Infarction: An Open, Prospective, Randomized, Multicentre Trial
- ClinicalTrials.gov ID
- NCT01930682
- Acronym / sponsor ID
- EARLY-MYO / BI135.326
- Keywords
- Myocardial Infarction, Catheterization, Fibrinolysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early post-fibrinolytic catheterisation | Experimental | Drug: Alteplase, Procedure: Early post-fibrinolytic catheterisationFor 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). |
| Primary PCI | Other | Procedure: Primary PCIFor STEMI Patients,primary PCI is performed without fibrinolytic therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- Evidence of cardiac rupture;
- ECG: new left bundle branch block;
- "Diagnosis to balloon inflation" time over 3 hours;
- Thrombolysis contradictions:
- Severe complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAlso: rt-PAAlteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min. | Drug | Early post-fibrinolytic catheterisation |
| Early post-fibrinolytic catheterisationEarly 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). | Procedure or surgery | Early post-fibrinolytic catheterisation |
| Primary PCIFor STEMI Patients,primary PCI is performed within 12 hours after the onset. | Procedure or surgery | Primary PCI |
Primary outcome
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
7 secondary outcomes
TIMI Flow Grade (TFG)
Time frame: Immediately after PCI
TIMI Myocardial Perfusion Grade (TMPG)
Time frame: Immediately after PCI
ST-segment Resolution
Time frame: Immediately after PCI
TIMI Frame Count (CTFC)
Time frame: Immediately after PCI
TIMI Myocardial Perfusion Frame Count (TMPFC)
Time frame: Immediately after PCI
Wall motion score index (WMSI) by echocardiography
Time frame: in-hospital and 30 day
Clinical Outcomes
Time frame: 30 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Background: PubMed 18191746Canadian 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.
- Background: PubMed 10366375Gibson 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.
- Background: PubMed 20601393Borgia 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.
- Background: PubMed 19004841Van 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.
- Background: PubMed 19960517Ding 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.
- Background: PubMed 17244641Fernandez-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.
- Derived from this study: PubMed 28844990Pu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben He, MD study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alteplase, Early post-fibrinolytic catheterisation and Primary PCI in people with Acute ST-segment Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Epicardial and myocardial reperfusion; (time frame: Immediately after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930682, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.