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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT00157261
Collaborator
(none)
1,050
Enrollment
68
Locations
29
Duration (Months)
15.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial
Study Start Date :
Jan 1, 2004
Primary Completion Date :
Jun 1, 2006
Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

  1. The primary endpoint of this study is the 30-day survival rate [30 days]

  2. The co-primary endpoint of this study is hospital admission [30 days]

Secondary Outcome Measures

  1. Return of spontaneous circulation (ROSC) [30 days]

  2. 24-hr survival [24 hours]

  3. Neurological and overall outcome at hospital discharge or at day 30, whichever came first [30 days]

  4. Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first [30 days]

  5. Major bleeds up to hospital discharge or day 30, whichever came first [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univ.-Klinik f. Anaesthesie Graz Graz Austria 8036
2 Univ.-Klinik f. Anaesthesie u. Intensivmedizin Innsbruck Austria 6020
3 LKH Salzburg, St. Johanns-Spital Salzburg Austria 5020
4 Univ.-Klinik f. Notfallmedizin Wien Austria 1090
5 Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg Antwerpen Belgium 2060
6 AZ Sint-Jan AV Brugge Belgium 8000
7 CHU Saint-Pierre Bruxelles Belgium 1000
8 AZ VUB Bruxelles Belgium 1090
9 Cliniques Universitaires Saint-Luc Bruxelles Belgium 1200
10 AZ Groeningen Kortrijk Belgium 8500
11 CHU de Tivoli La Louvière Belgium 7100
12 Universitaire Ziekenhuizen Leuven Leuven Belgium 3000
13 CHR de la Citadelle Liège Belgium 4000
14 CHR de Namur Namur Belgium 5000
15 Hôpital Jean Minjoz Besançon cedex France 25030
16 Hôpital Avicenne Bobigny cedex France 93009
17 Hôpital Henri Mondor Creteil cedex France 94010
18 Hôpital André Mignot Le Chesnay France 78150
19 Hôpital Régional et Universitaire Lille cedex France 59037
20 Hôpital Marc Jacquet Melun cedex France 77011
21 Hôpital Lapeyronie Montpellier cedex 5 France 34295
22 Hôpital Necker Paris cedex 15 France 75743
23 Hôpital Charles Nicolle Rouen cedex France 76031
24 Hôpital Purpan Toulouse cedex France 31059
25 Hôpital Pierre Bazin Voiron cedex France 38506
26 Universitätsklinikum Benjamin Franklin Berlin Germany 12200
27 Humboldt-Klinikum Berlin Germany 13504
28 DRK Kliniken Westend Berlin Germany 14050
29 Städtische Kliniken Bielefeld gem. GmbH Bielefeld Germany 33604
30 Klinikum der Ruhr-Universität Bochum Bochum Germany 44791
31 Knappschaftskrankenhaus Dortmund Dortmund Germany 44309
32 Chirurgische Universität Freiburg Freiburg/Breisgau Germany 79106
33 Georg-August Universität Göttingen Göttingen Germany 37075
34 Martin-Luther-Universität Halle Halle/Saale Germany 06120
35 Universität Heidelberg Heidelberg Germany 69120
36 Friedrich-Schiller Universität Jena Jena Germany 07740
37 Universitätsklinikum Schleswig-Holstein Kiel Germany 24105
38 Berufsfeuerwehr Kiel Kiel Germany 24116
39 Universitätsklinikum Mannheim Mannheim Germany 68168
40 Klinikum rechts der Isar München Germany 81675
41 Klinikum Saarbrücken gGmbH Saarbrücken Germany 66119
42 Universitätsklinikum Ulm Ulm Germany 89075
43 A. O. Ospedali Riuniti di Bergamo Bergamo Italy 24100
44 Ospedale S. Anna Como Italy 22100
45 A. O. Universitaria S. Martino Genova Italy 16132
46 A. O. San Gerardo di Monza Monza Italy 20052
47 Policlinico S. Matteo Pavia Italy 27100
48 Osp. di Circolo Fondazione Macchi Varese Italy 21100
49 ICU, Haukeland Universitetssykehus Bergen Norway N-5021
50 ICU, Sykehuset Østfold Fredrikstad Fredrikstad Norway N-1603
51 Akuttklinikken / NLA, Sentralsjukehuset i Rogaland Stavanger Norway N-4068
52 Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg Tønsberg Norway N-3101
53 Hospital de Torrecárdenas / ICU Almería Spain 04009
54 Hospital Clínico Provincial de BCN / Cardiology Service Barcelona Spain 08036
55 Hospital Universitario Reina Sofía / ICU Cordoba Spain 14004
56 Vírgen de las Nieves. Critical Care-Emergency Room Granada Spain 18012
57 Hospital de Jerez de la Frontera / ICU Jerez de la Frontera Spain 11407
58 Hospital Clínico San Carlos / Hemodynamics Madrid Spain 28040
59 Hospital Clínico Universitario Vírgen de la Victoria / ICU Malaga Spain 29010
60 Boehringer Ingelheim Investigational Site Sevilla Spain 41014
61 Complejo Hospitalario Universitario de Vigo / Cardiology Vigo Spain 36214
62 Hospital Clinico Univ. Lozano Blesa Zaragoza Spain 50009
63 Anestesikliniken Gävle Sweden 807 87
64 Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg Göteborg Sweden 413 45
65 Södersjukhuset Stockholm Sweden 118 83
66 Universitetssjukhuset Örebro Sweden 701 85
67 Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429 Lausanne Switzerland 1005
68 Boehringer Ingelheim Investigational Site Lugano Switzerland 6900

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Pharma GmbH & Co. KG

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00157261
Other Study ID Numbers:
  • 1123.18
First Posted:
Sep 12, 2005
Last Update Posted:
Oct 29, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Heart Arrest
Tenecteplase

Study Results

No Results Posted as of Oct 29, 2013