Clinical trial NCT00220571: CARESS in Acute Myocardial Infarction
Official title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: AMI
stent
PTCA
abciximab
reteplase
combo therapy
Lead sponsor: Società Italiana di Cardiologia Invasiva
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: Eli Lilly and Company
name: Biotronik SE & Co. KG
First posted: 2005-09-22
Enrollment: 600
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

* 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: All patients with ST-segment elevation AMI admitted within 12 hours from symptoms onset will be screened to enter in this study. Data of patients with ST-segment elevation AMI within 12 hours from symptoms onset who do not meet the inclusion criteria or do not sign the informed consent form are entered into a dedicated registry.

Eligibility criteria: Inclusion Criteria:

- ECG with ST-elevation (≥ 1mm in at least 2 ECG limb leads or ≥ 2 mm in 2 contiguous precordial leads) AMI within \<12 hours from symptoms onset fulfilling 1 or more of the following criteria of "high risk":

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:

1. Inability to provide informed consent;
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.).

Primary outcomes:
measure: To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.
timeFrame: 30 Day
Secondary outcomes:
measure: Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;
timeFrame: 1 Year
measure: Compare the resource use at 30 days and 1 year, including days in CCU, MICU or general ward, cost of catheterization and PTCA, drugs, ambulance service during index hospitalization and subsequent hospital admissions for reAMI
timeFrame: 30 Day and 1 Year
measure: Compare the incidence of in-hospital stroke and bleeding complications in the two arms.
timeFrame: 30 Day
Other outcomes:
Locations:
city: Avignon
country: France
facility: Cardiologie Hop. Duffaut
city: Avignon
country: France
facility: SAMU - Hop. Duffaut
city: Bron
country: France
facility: Cardiologie - Hop. Louis Pradel
city: Caen
country: France
facility: Cardiologie - CH
city: Carpentras
country: France
facility: Urgences - CH
city: Cherbourg
country: France
facility: Cardiologie - CH
city: Clichy
country: France
facility: SAMU - Hop. Beaujon
city: Colmar
country: France
facility: Service de Cardiologie - Hopital St. Joseph
city: Grenoble
country: France
facility: Cardiologie - CHU
city: Grenoble
country: France
facility: Samu - Chu
city: Lyon
country: France
facility: SAMU 69 - Hop. E. Herriot
city: Paris
country: France
facility: Cardiologie - Hop. Bichat
city: Selestat
country: France
facility: SAMU - Reanimation - CH
city: St. Denis
country: France
facility: Centre Cardiologique du Nord
city: St. Denis
country: France
facility: SMUR Delafontaine
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Bibbiena
country: Italy
facility: Presidio Ospedaliero del Casentino
city: Brescia
country: Italy
facility: Spedali Civili
city: Busto Arsizio
country: Italy
facility: Az. Ospedaliera di Circolo
city: Camposampiero
country: Italy
facility: P.O. di Camposampiero
city: Carpi
country: Italy
facility: Ospedale Ramazzini
city: Cesena
country: Italy
facility: Ospedale Bufalini
city: Cittadella
country: Italy
facility: P.O. Cittadella
city: Codogno
country: Italy
facility: P.O. di Codogno
city: Conegliano
country: Italy
facility: Ospedale di Conegliano
city: Copertino
country: Italy
facility: Ospedale S. Giuseppe da Copertino
city: cORREGGIO
country: Italy
facility: Ospedale S. Sebastiano
city: Cortona
country: Italy
facility: P.O. di Cortona
city: Cuneo
country: Italy
facility: Ospedale Santa Croce e Carle
city: Desio
country: Italy
facility: Ospedale di Desio
city: Feltre
country: Italy
facility: Ospedale Santa Maria del Prato
city: Frascati
country: Italy
facility: Ospedale S. Sebastiano Martire
city: Galatina
country: Italy
facility: Ospedale Santa Caterina Novella
city: Gavardo
country: Italy
facility: Ospedale La Memoria
city: Giugliano
country: Italy
facility: Ospedale San Giuliano
city: Guastalla
country: Italy
facility: Ospedale di Guastalla
city: Lecce
country: Italy
facility: Az. Osp.Vito Fazzi
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
city: Manerbio
country: Italy
facility: Az. Ospedaliera Desenzano sul Garda
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor IRCCS
city: Modena
country: Italy
facility: Hesperia Hospital
city: Modena
country: Italy
facility: Nuovo Ospedale S. Agostino Estense - Baggiovara
city: Mondovi
country: Italy
facility: Ospedale Civile
city: Montebelluna
country: Italy
facility: P.O. di Montebelluna
city: Montecchio
country: Italy
facility: Ospedale Franchini
city: Napoli
country: Italy
facility: Azienda Universitaria Federico II
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria delle Grazie
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Riccione
country: Italy
facility: Ospedale Civile
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: A.O. San Camillo
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Valdarno
country: Italy
facility: P.O. U.O. Struttura Complessa
city: Sansepolcro
country: Italy
facility: Ospedale della Valtiberina
city: Saronno
country: Italy
facility: Ospedale Provinciale di Saronno
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo
city: Savigliano
country: Italy
facility: Ospedale SS.Annunziata
city: Scafati
country: Italy
facility: Ospedale M. Scarlato
city: Scandiano
country: Italy
facility: Ospedale Magati
city: Tradate
country: Italy
facility: Az. Ospedaliera Galmarini
city: Treviso
country: Italy
facility: Ospedale Cà Foncello
city: Bedzin
country: Poland
facility: Specjalista Chorob Wewnetryznich
city: Brzesku
country: Poland
facility: Oddzial Chorob Wewnetrznych
city: Chrzanow
country: Poland
facility: Szpital Powiatowy w Chrzanowie
city: Dabrowa Gornicza
country: Poland
facility: Oddzialu Kardiologicznego
city: Dabrowa Tarnowska
country: Poland
facility: Oddzialu Chorob Wewnetrznych
city: Jaworzno
country: Poland
facility: II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie
city: Katovice
country: Poland
facility: First Dept. Cardiology - Gornoslaskiego Centrum Medycznego
city: Katowice
country: Poland
facility: Oddzial Wewneztrnj Okregowy Szpital Kolciowy
city: Krakow
country: Poland
facility: Zaklad Hemodynamiki i Angiokardiografii Pracownia 1
city: Krakow
country: Poland
facility: Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2
city: Krynica
country: Poland
facility: Oddzial Wewnetrzny - Szpital Mijski w Krynicy
city: Limanowa
country: Poland
facility: Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej
city: Nowy Sacz
country: Poland
facility: Oddzial Internistyczno- kardiologiczny
city: Nowy Targ
country: Poland
facility: Oddzial Kardiologiczny
city: Oswiecim
country: Poland
facility: Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu
city: Sosnowiec
country: Poland
facility: Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej
city: Sucha Beskidzka
country: Poland
facility: Zaklad Opieki Zdrowotnej
city: Szczyrzyc
country: Poland
facility: Oddzial Wewnetrzny Szpital w Szczyrzu
city: Tarnow
country: Poland
facility: Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika
city: Tarnow
country: Poland
facility: Oddzialu Kardiologii z OIOK
city: Tychy
country: Poland
facility: Oddzial Kardiologii - Szpital Miejski w Tychach
city: Wadowice
country: Poland
facility: Szpital Powiatowy im. Jana Pawla II w Wadowicach
city: Zakopane
country: Poland
facility: Oddzial Kardiologii - Szpital Powiatowy w Zakopane
Study officials:
affiliation: Ospedale San Donato - Arezzo Italy
name: Leonardo Bolognese, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Bichat - Paris France
name: Gabriel P. Steg, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Jagellonian University Krakow Poland
name: Darius Dudek, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton and Harefield Hospital - London UK
name: Carlo Di Mario, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.