CARESS in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220571
• Other study ID #: IIT(IT) H4S-IT-O038
• Secondary ID: 2003OE001B
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 2, 2007
• Start date: May 2003
• Est. completion date: March 2007

Study information

• Verified date: September 2005
• Source: Società Italiana di Cardiologia Invasiva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthFrance: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Coronary Angioplasty (PTCA)

Locations

Country	Name	City	State
France	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	SAMU - Reanimation - CH	Selestat
France	Centre Cardiologique du Nord	St. Denis
France	SMUR Delafontaine	St. Denis
Italy	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
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	Milano
Italy	Hesperia Hospital	Modena
Italy	Nuovo Ospedale S. Agostino Estense - Baggiovara	Modena
Italy	Ospedale Civile	Mondovi
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	A.O. San Camillo	Roma
Italy	Ospedale S. Eugenio	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
Poland	Specjalista Chorob Wewnetryznich	Bedzin
Poland	Oddzial Chorob Wewnetrznych	Brzesku
Poland	Szpital Powiatowy w Chrzanowie	Chrzanow
Poland	Oddzialu Kardiologicznego	Dabrowa Gornicza
Poland	Oddzialu Chorob Wewnetrznych	Dabrowa Tarnowska
Poland	II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie	Jaworzno
Poland	First Dept. Cardiology - Gornoslaskiego Centrum Medycznego	Katovice
Poland	Oddzial Wewneztrnj Okregowy Szpital Kolciowy	Katowice
Poland	Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2	Krakow
Poland	Zaklad Hemodynamiki i Angiokardiografii Pracownia 1	Krakow
Poland	Oddzial Wewnetrzny - Szpital Mijski w Krynicy	Krynica
Poland	Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej	Limanowa
Poland	Oddzial Internistyczno- kardiologiczny	Nowy Sacz
Poland	Oddzial Kardiologiczny	Nowy Targ
Poland	Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu	Oswiecim
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	Tarnow
Poland	Oddzialu Kardiologii z OIOK	Tarnow
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

Sponsors (4)

Lead Sponsor	Collaborator
Società Italiana di Cardiologia Invasiva	Biotronik SE & Co. KG, Eli Lilly and Company, Royal Brompton & Harefield NHS Foundation Trust

Countries where clinical trial is conducted

France,  Italy,  Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.		30 Day
Secondary	Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;		1 Year
Secondary	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		30 Day and 1 Year
Secondary	Compare the incidence of in-hospital stroke and bleeding complications in the two arms.		30 Day