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Myocardial InfarctionPhase 3NCT00220571

CARESS in Acute Myocardial Infarction

A Phase 3 study testing Coronary Angioplasty (PTCA) in people with Myocardial Infarction, run by Società Italiana di Cardiologia Invasiva at 85 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Coronary Angioplasty (PTCA)
Type of treatment
Medical device
How many people
600 participants
Where
85 sitesin 3 countries
Study dates
May 2003to Mar 2007
Phase
Phase 3
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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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":
  • Summation of ST-segment elevation or depression ≥ 15 mm in all 12 electrocardiographic leads or new onset complete left bundle branch block;
  • Previous myocardial infarction (Q- and non Q-wave);
  • Killip Class 2 or 3;
  • LV ejection fraction at transthoracic ultrasound < 40%.

Who cannot join

  • Inability to provide informed consent;
  • Age > 75 years
  • CABG or PCI procedure in past history involving the infarct-related artery;
  • Participation in another study with any investigational drug or device within the previous 30 days;
  • Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer);
  • 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);
Show all 26Show fewer
  • 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);
  • Severe hepatic disease;
  • Patients with acute or chronic renal impairment (serum creatinine > 2.0 mg % or 200 mg/l or creatinine clearance < 30 ml/min);
  • Transmural MI in different location within the previous week;
  • Previous administration of thrombolytics within 7 days;
  • Intolerance or contraindications to ASA or Clopidogrel;
  • Known leucopenia, defined as a leukocyte count of < 3.500 White Blood Cells (WBC)/ml
  • Known neutropenia, defined as < 1000 neutrophils / ml;
  • Known thrombocytopenia (< 100.000 platelets / ml );
  • Documented active peptic ulcer or upper gastrointestinal bleeding within the previous 6 months;
  • Previous hemorrhagic stroke;
  • Previous ischemic cerebrovascular event within 3 months;
  • Intracranial neoplasm;
  • Recent major surgery at risk of bleeding;
  • Episodes of uncontrolled hypertension (> 180/110 mmHg despite treatment) in past 2 years;
  • Administration of oral anticoagulants within the previous 7 days unless INR ≤ 1.2;
  • Severe recent trauma;
  • Known or possible pregnancy;
  • Absence of suitable vascular access (diffuse peripheral arterial disease);
  • Basal ECG changes which make identification of ST-segment elevation impossible (i.e.: ventricular activation from artificial pacemaker, etc.).

Trial locations and contacts

85 sites in 3 countries.

85 sites in 3 countries

Italy47 sites

  • Ospedale San Donato

    Arezzo, 50100

  • Presidio Ospedaliero del Casentino

    Bibbiena, 52011

  • Spedali Civili

    Brescia, 25123

  • Az. Ospedaliera di Circolo

    Busto Arsizio, 21052

  • P.O. di Camposampiero

    Camposampiero, 35012

  • Ospedale Ramazzini

    Carpi, 41012

  • Ospedale Bufalini

    Cesena, 47023

  • P.O. Cittadella

    Cittadella, 35013

  • P.O. di Codogno

    Codogno, 26845

  • Ospedale di Conegliano

    Conegliano, 31015

  • Ospedale S. Giuseppe da Copertino

    Copertino, 73043

  • Ospedale S. Sebastiano

    Correggio, 42015

  • P.O. di Cortona

    Cortona, 52044

  • Ospedale Santa Croce e Carle

    Cuneo, 12100

  • Ospedale di Desio

    Desio, 20033

  • Ospedale Santa Maria del Prato

    Feltre, 32032

  • Ospedale S. Sebastiano Martire

    Frascati, 00044

  • Ospedale Santa Caterina Novella

    Galatina, 73013

  • Ospedale La Memoria

    Gavardo, 25085

  • Ospedale San Giuliano

    Giugliano in Campania, 80014

  • Ospedale di Guastalla

    Guastalla, 42016

  • Az. Osp.Vito Fazzi

    Lecce, 73100

  • Ospedale Civile di Legnano

    Legnano, 20025

  • Az. Ospedaliera Desenzano sul Garda

    Manerbio, 25025

  • Fondazione Centro San Raffaele del Monte Tabor IRCCS

    Milan, 20132

  • Hesperia Hospital

    Modena, 41100

  • Nuovo Ospedale S. Agostino Estense - Baggiovara

    Modena, 41100

  • Ospedale Civile

    Mondovì, 12084

  • P.O. di Montebelluna

    Montebelluna, 31044

  • Ospedale Franchini

    Montecchio, 42027

  • Azienda Universitaria Federico II

    Naples, 80131

  • Ospedale Santa Maria delle Grazie

    Pozzuoli, 80078

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Ospedale Civile

    Riccione, 47038

  • Ospedale degli Infermi

    Rimini, 47900

  • Ospedale S. Eugenio

    Roma, 00100

  • A.O. San Camillo

    Roma, 00152

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • P.O. U.O. Struttura Complessa

    San Giovanni Valdarno, 52027

  • Ospedale della Valtiberina

    Sansepolcro, 52037

  • Ospedale Provinciale di Saronno

    Saronno, 21047

  • Nuovo Ospedale Civile di Sassuolo

    Sassuolo, 41049

  • Ospedale SS.Annunziata

    Savigliano, 12028

  • Ospedale M. Scarlato

    Scafati, 84018

  • Ospedale Magati

    Scandiano, 42010

  • Az. Ospedaliera Galmarini

    Tradate, 21049

  • Ospedale Cà Foncello

    Treviso, 31100

Other trials in Italy

Poland23 sites

  • Specjalista Chorob Wewnetryznich

    Będzin, 42500

  • Oddzial Chorob Wewnetrznych

    Brzesku, 32800

  • Szpital Powiatowy w Chrzanowie

    Chrzanów, 32500

  • Oddzialu Kardiologicznego

    Dąbrowa Górnicza, 41300

  • Oddzialu Chorob Wewnetrznych

    Dąbrowa Tarnowska, 32200

  • II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie

    Jaworzno, 43600

  • Oddzial Wewneztrnj Okregowy Szpital Kolciowy

    Katowice, 40760

  • First Dept. Cardiology - Gornoslaskiego Centrum Medycznego

    Katowice, 41635

  • Zaklad Hemodynamiki i Angiokardiografii Pracownia 1

    Krakow, 31202

  • Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2

    Krakow, 31501

  • Oddzial Wewnetrzny - Szpital Mijski w Krynicy

    Krynica, 33380

  • Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej

    Limanowa, 34600

  • Oddzial Internistyczno- kardiologiczny

    Nowy Sącz, 33300

  • Oddzial Kardiologiczny

    Nowy Targ, 34400

  • Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu

    Oświęcim, 32600

  • Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej

    Sosnowiec, 41200

  • Zaklad Opieki Zdrowotnej

    Sucha Beskidzka, 34-200

  • Oddzial Wewnetrzny Szpital w Szczyrzu

    Szczyrzyc, 34623

  • Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika

    Tarnów, 33100

  • Oddzialu Kardiologii z OIOK

    Tarnów, 33100

  • Oddzial Kardiologii - Szpital Miejski w Tychach

    Tychy, 43100

  • Szpital Powiatowy im. Jana Pawla II w Wadowicach

    Wadowice, 34100

  • Oddzial Kardiologii - Szpital Powiatowy w Zakopane

    Zakopane, 34500

Other trials in Poland

France15 sites

  • Cardiologie Hop. Duffaut

    Avignon, 84902

  • SAMU - Hop. Duffaut

    Avignon, 84902

  • Cardiologie - Hop. Louis Pradel

    Bron, 69500

  • Cardiologie - CH

    Caen, 14033

  • Urgences - CH

    Carpentras, 84200

  • Cardiologie - CH

    Cherbourg, 50100

  • SAMU - Hop. Beaujon

    Clichy, 92110

  • Service de Cardiologie - Hopital St. Joseph

    Colmar, 68024

  • Cardiologie - CHU

    Grenoble, 38043

  • Samu - Chu

    Grenoble, 38043

  • SAMU 69 - Hop. E. Herriot

    Lyon, 69437

  • Cardiologie - Hop. Bichat

    Paris, 75018

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

  • SMUR Delafontaine

    Saint-Denis, 93200

  • SAMU - Reanimation - CH

    Sélestat, 67604

Other trials in France

About this study

Official title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

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
Read the 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.

Being tested
Coronary Angioplasty (PTCA)
Keywords
AMI, stent, PTCA, abciximab, reteplase, combo therapy
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Angioplasty (PTCA)Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study.

    Measured: 30 Day

Secondary outcomes (3)

  1. Compare 1 year composite end-point of: mortality, reinfarction, refractory ischemia, hospital readmission because of heart failure in the two arms;

    Measured: 1 Year

  2. 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

    Measured: 30 Day and 1 Year

  3. Compare the incidence of in-hospital stroke and bleeding complications in the two arms.

    Measured: 30 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startMay 2003
  3. Study completionMar 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00220571
Sponsor's protocol ID
IIT(IT) H4S-IT-O038
Other IDs
2003OE001B
Status last verified
Sep 2005
First submitted
13 Sep 2005
Last updated
3 Jul 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15389222

  • 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.

    PubMed 18280326

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coronary Angioplasty (PTCA) in people with Myocardial Infarction, run by Società Italiana di Cardiologia Invasiva at 85 sites in 3 countries.

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 5 inclusion and 26 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 3 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in Italy, Poland, France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To compare 30 days incidence of the composite end-point of: mortality, reinfarction and refractory ischemia in the two arms of the study. (time frame: 30 Day). 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 NCT00220571, which also lists 2 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 3 Jul 2007.

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