Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest. The TROICA Trial.

Condition(s) targeted: Heart Arrest

Intervention: tenecteplase (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Pharma GmbH & Co. KG

The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

Official title: A Prospective, Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Parallel-Group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-Hospital Cardiac Arre

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint of this study is the 30-day survival rate. The co-primary endpoint of this study is hospital admission.

Secondary outcome: Return of spontaneous circulation, 24-hr survival, survival to hospital discharge or day 30 whichever is first, distribution of neurological and overall outcome scores.

Detailed description: The trial is a prospective, international, multi-centre, randomised (1: 1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.

Approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.

PCI facilities will be required at all participating sites, i. e. hospitals receiving patients.

Study Hypothesis:

The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).

Comparison(s):

Group A (experimental; fibrinolytic treatment) Tenecteplase, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Group B (reference) Placebo, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Patients, indicated for pre-hospital ALS-CPR procedures* must fulfil the following inclusion criteria:

- Age at least 18 years (known or estimated; no upper limit)

- Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac

arrest(s) after initial ROSC)

- Witnessed (by eye and/or ear) cardiac arrest

- BLS-CPR started within 10 min of onset (known or estimated time) and may be performed

for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset

(known or estimated time)

Subjects who meet any of the following criteria will be excluded from randomisation into the study:

- In-hospital cardiac arrest

- Cardiac arrest of presumed non-cardiac origin (e. g. drug overdose, carbon monoxide

poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)

- Obvious significant internal bleeding

- Known neurological impairment

- Known coagulation disorder

- Known pregnancy

- Known current participation in any other clinical study

- Known hypersensitivity to study medication

- Institutionalised subjects (e. g. prisoner)

- Any other condition that the investigator feels would place the patient at increased

risk if the investigational therapy is initiated

Univ.-Klinik f. Notfallmedizin, Wien 1090, Austria

Univ.-Klinik f. Anaesthesie Graz, Graz 8036, Austria

Univ.-Klinik f. Anaesthesie u. Intensivmedizin, Innsbruck 6020, Austria

LKH Salzburg, St. Johanns-Spital, Salzburg 5020, Austria

Universitaire Ziekenhuizen Leuven, Leuven 3000, Belgium

AZ VUB, Bruxelles 1090, Belgium

AZ Sint-Jan AV, Brugge 8000, Belgium

CHR de Namur, Namur 5000, Belgium

CHU de Tivoli, La Louvière 7100, Belgium

CHU Saint-Pierre, Bruxelles 1000, Belgium

Cliniques Universitaires Saint-Luc, Bruxelles 1200, Belgium

Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg, Antwerpen 2060, Belgium

CHR de la Citadelle, Liège 4000, Belgium

AZ Groeningen, Kortrijk 8500, Belgium

Hôpital Necker, Paris cedex 15 75743, France

Hôpital Avicenne, Bobigny cedex 93009, France

Hôpital Régional et Universitaire, Lille cedex 59037, France

Hôpital Lapeyronie, Montpellier cedex 5 34295, France

Hôpital Henri Mondor, Creteil cedex 94010, France

Hôpital Purpan, Toulouse cedex 31059, France

Hôpital Charles Nicolle, Rouen cedex 76031, France

Hôpital Pierre Bazin, Voiron cedex 38506, France

Hôpital André Mignot, Le Chesnay 78150, France

Hôpital Marc Jacquet, Melun cedex 77011, France

Hôpital Jean Minjoz, Besançon cedex 25030, France

Universitätsklinikum Benjamin Franklin, Berlin 12200, Germany

DRK Kliniken Westend, Berlin 14050, Germany

Humboldt-Klinikum, Berlin 13504, Germany

Klinikum der Ruhr-Universität Bochum, Bochum 44791, Germany

Universität Heidelberg, Heidelberg 69120, Germany

Klinikum Saarbrücken gGmbH, Saarbrücken 66119, Germany

Städtische Kliniken Bielefeld gem. GmbH, Bielefeld 33604, Germany

Chirurgische Universität Freiburg, Freiburg/Breisgau 79106, Germany

Universitätsklinikum Mannheim, Mannheim 68168, Germany

Martin-Luther-Universität Halle, Halle/Saale 06120, Germany

Universitätsklinikum Ulm, Ulm 89075, Germany

Friedrich-Schiller Universität Jena, Jena 07740, Germany

Knappschaftskrankenhaus Dortmund, Dortmund 44309, Germany

Klinikum rechts der Isar, München 81675, Germany

Berufsfeuerwehr Kiel, Kiel 24116, Germany

Universitätsklinikum Schleswig-Holstein, Kiel 24105, Germany

Georg-August Universität Göttingen, Göttingen 37075, Germany

A. O. San Gerardo di Monza, MONZA 20052, Italy

Ospedale S. Anna, COMO 22100, Italy

Policlinico S. Matteo, PAVIA 27100, Italy

A. O. Ospedali Riuniti di Bergamo, Bergamo 24100, Italy

Osp. di Circolo Fondazione Macchi, VARESE 21100, Italy

A. O. Universitaria S. Martino, GENOVA 16132, Italy

Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg, TØNSBERG N-3101, Norway

ICU, Haukeland Universitetssykehus, BERGEN N-5021, Norway

Akuttklinikken / NLA, Sentralsjukehuset i Rogaland, STAVANGER N-4068, Norway

ICU, Sykehuset Østfold Fredrikstad, FREDRIKSTAD N-1603, Norway

Hospital Clínico Provincial de BCN / Cardiology Service, Barcelona 08036, Spain

Hospital Clínico San Carlos / Hemodynamics, Madrid 28040, Spain

Hospital Clínico Universitario Vírgen de la Victoria / ICU, Malaga 29010, Spain

Boehringer Ingelheim Investigational Site, Sevilla 41014, Spain

Vírgen de las Nieves. Critical Care-Emergency Room, Granada 18012, Spain

Hospital Clinico Univ. Lozano Blesa, Zaragoza 50009, Spain

Complejo Hospitalario Universitario de Vigo / Cardiology, Vigo 36214, Spain

Hospital de Torrecárdenas / ICU, Almería 04009, Spain

Hospital de Jerez de la Frontera / ICU, Jerez de la Frontera 11407, Spain

Hospital Universitario Reina Sofía / ICU, Cordoba 14004, Spain

Södersjukhuset, Stockholm 118 83, Sweden

Universitetssjukhuset, Örebro 701 85, Sweden

Anestesikliniken, Gävle 807 87, Sweden

Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg, Göteborg 413 45, Sweden

Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429, Lausanne 1005, Switzerland

Boehringer Ingelheim Investigational Site, Lugano 6900, Switzerland

Starting date: January 2004
Ending date: June 2006
Last updated: January 12, 2007