Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2003-05-31
2007-03-31
Brief Summary
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* Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
* Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Coronary Angioplasty (PTCA)
Eligibility Criteria
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Inclusion Criteria
1. Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
2. Previous myocardial infarction (Q- and non Q-wave);
3. Killip Class 2 or 3;
4. LV ejection fraction at transthoracic ultrasound \< 40%.
Exclusion Criteria
2. Age \> 75 years
3. CABG or PCI procedure in past history involving the infarct-related artery;
4. Participation in another study with any investigational drug or device within the previous 30 days;
5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
6. Cardiogenic shock (hypotension with Systolic Blood Pressure (SBP) \< 90 mmHg and tachycardia \> 100 beats / min, not due to hypovolemia and requiring inotropic support or balloon counterpulsation);
7. Need for concomitant major surgery (e.g. valve surgery or resection of aortic or left ventricular aneurysm, carotid endarterectomy, abdominal aortic aneurysm surgery, congenital heart disease etc);
8. Severe hepatic disease;
9. Patients with acute or chronic renal impairment (serum creatinine \> 2.0 mg % or 200 mg/l or creatinine clearance \< 30 ml/min);
10. Transmural MI in different location within the previous week;
11. Previous administration of thrombolytics within 7 days;
12. Intolerance or contraindications to ASA or Clopidogrel;
13. Known leucopenia, defined as a leukocyte count of \< 3.500 White Blood Cells (WBC)/ml
14. Known neutropenia, defined as \< 1000 neutrophils / ml;
15. Known thrombocytopenia (\< 100.000 platelets / ml );
16. Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
17. Previous hemorrhagic stroke;
18. Previous ischemic cerebrovascular event within 3 months;
19. Intracranial neoplasm;
20. Recent major surgery at risk of bleeding;
21. Episodes of uncontrolled hypertension (\> 180/110 mmHg despite treatment) in past 2 years;
22. Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
23. Severe recent trauma;
24. Known or possible pregnancy;
25. Absence of suitable vascular access (diffuse peripheral arterial disease);
26. Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).
75 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Eli Lilly and Company
INDUSTRY
Biotronik SE & Co. KG
INDUSTRY
Società Italiana di Cardiologia Invasiva
OTHER
Principal Investigators
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Leonardo Bolognese, MD, Ph D
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Donato - Arezzo Italy
Gabriel P. Steg, MD. Ph D
Role: PRINCIPAL_INVESTIGATOR
Hopital Bichat - Paris France
Darius Dudek, MD, Ph D
Role: PRINCIPAL_INVESTIGATOR
Jagellonian University Krakow Poland
Carlo Di Mario, MD
Role: STUDY_CHAIR
Royal Brompton and Harefield Hospital - London UK
Locations
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Cardiologie Hop. Duffaut
Avignon, , France
SAMU - Hop. Duffaut
Avignon, , France
Cardiologie - Hop. Louis Pradel
Bron, , France
Cardiologie - CH
Caen, , France
Urgences - CH
Carpentras, , France
Cardiologie - CH
Cherbourg, , France
SAMU - Hop. Beaujon
Clichy, , France
Service de Cardiologie - Hopital St. Joseph
Colmar, , France
Cardiologie - CHU
Grenoble, , France
Samu - Chu
Grenoble, , France
SAMU 69 - Hop. E. Herriot
Lyon, , France
Cardiologie - Hop. Bichat
Paris, , France
Centre Cardiologique du Nord
Saint-Denis, , France
SMUR Delafontaine
Saint-Denis, , France
SAMU - Reanimation - CH
Sélestat, , France
Ospedale San Donato
Arezzo, , Italy
Presidio Ospedaliero del Casentino
Bibbiena, , Italy
Spedali Civili
Brescia, , Italy
Az. Ospedaliera di Circolo
Busto Arsizio, , Italy
P.O. di Camposampiero
Camposampiero, , Italy
Ospedale Ramazzini
Carpi, , Italy
Ospedale Bufalini
Cesena, , Italy
P.O. Cittadella
Cittadella, , Italy
P.O. di Codogno
Codogno, , Italy
Ospedale di Conegliano
Conegliano, , Italy
Ospedale S. Giuseppe da Copertino
Copertino, , Italy
Ospedale S. Sebastiano
Correggio, , Italy
P.O. di Cortona
Cortona, , Italy
Ospedale Santa Croce e Carle
Cuneo, , Italy
Ospedale di Desio
Desio, , Italy
Ospedale Santa Maria del Prato
Feltre, , Italy
Ospedale S. Sebastiano Martire
Frascati, , Italy
Ospedale Santa Caterina Novella
Galatina, , Italy
Ospedale La Memoria
Gavardo, , Italy
Ospedale San Giuliano
Giugliano in Campania, , Italy
Ospedale di Guastalla
Guastalla, , Italy
Az. Osp.Vito Fazzi
Lecce, , Italy
Ospedale Civile di Legnano
Legnano, , Italy
Az. Ospedaliera Desenzano sul Garda
Manerbio, , Italy
Fondazione Centro San Raffaele del Monte Tabor IRCCS
Milan, , Italy
Hesperia Hospital
Modena, , Italy
Nuovo Ospedale S. Agostino Estense - Baggiovara
Modena, , Italy
Ospedale Civile
Mondovì, , Italy
P.O. di Montebelluna
Montebelluna, , Italy
Ospedale Franchini
Montecchio, , Italy
Azienda Universitaria Federico II
Napoli, , Italy
Ospedale Santa Maria delle Grazie
Pozzuoli, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Ospedale Civile
Riccione, , Italy
Ospedale degli Infermi
Rimini, , Italy
Ospedale S. Eugenio
Roma, , Italy
A.O. San Camillo
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
P.O. U.O. Struttura Complessa
San Giovanni Valdarno, , Italy
Ospedale della Valtiberina
Sansepolcro, , Italy
Ospedale Provinciale di Saronno
Saronno, , Italy
Nuovo Ospedale Civile di Sassuolo
Sassuolo, , Italy
Ospedale SS.Annunziata
Savigliano, , Italy
Ospedale M. Scarlato
Scafati, , Italy
Ospedale Magati
Scandiano, , Italy
Az. Ospedaliera Galmarini
Tradate, , Italy
Ospedale Cà Foncello
Treviso, , Italy
Specjalista Chorob Wewnetryznich
Będzin, , Poland
Oddzial Chorob Wewnetrznych
Brzesku, , Poland
Szpital Powiatowy w Chrzanowie
Chrzanów, , Poland
Oddzialu Kardiologicznego
Dąbrowa Górnicza, , Poland
Oddzialu Chorob Wewnetrznych
Dąbrowa Tarnowska, , Poland
II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie
Jaworzno, , Poland
Oddzial Wewneztrnj Okregowy Szpital Kolciowy
Katowice, , Poland
First Dept. Cardiology - Gornoslaskiego Centrum Medycznego
Katowice, , Poland
Zaklad Hemodynamiki i Angiokardiografii Pracownia 1
Krakow, , Poland
Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2
Krakow, , Poland
Oddzial Wewnetrzny - Szpital Mijski w Krynicy
Krynica, , Poland
Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej
Limanowa, , Poland
Oddzial Internistyczno- kardiologiczny
Nowy Sącz, , Poland
Oddzial Kardiologiczny
Nowy Targ, , Poland
Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu
Oświęcim, , Poland
Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej
Sosnowiec, , Poland
Zaklad Opieki Zdrowotnej
Sucha Beskidzka, , Poland
Oddzial Wewnetrzny Szpital w Szczyrzu
Szczyrzyc, , Poland
Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika
Tarnów, , Poland
Oddzialu Kardiologii z OIOK
Tarnów, , Poland
Oddzial Kardiologii - Szpital Miejski w Tychach
Tychy, , Poland
Szpital Powiatowy im. Jana Pawla II w Wadowicach
Wadowice, , Poland
Oddzial Kardiologii - Szpital Powiatowy w Zakopane
Zakopane, , Poland
Countries
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References
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Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85. doi: 10.1016/j.ahj.2004.03.038.
Di Mario C, Dudek D, Piscione F, Mielecki W, Savonitto S, Murena E, Dimopoulos K, Manari A, Gaspardone A, Ochala A, Zmudka K, Bolognese L, Steg PG, Flather M; CARESS-in-AMI (Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction) Investigators. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008 Feb 16;371(9612):559-68. doi: 10.1016/S0140-6736(08)60268-8.
Other Identifiers
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2003OE001B
Identifier Type: -
Identifier Source: secondary_id
IIT(IT) H4S-IT-O038
Identifier Type: -
Identifier Source: org_study_id