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

Primary Purpose

Heart Arrest

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tenecteplase
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univ.-Klinik f. Anaesthesie Graz
  • Univ.-Klinik f. Anaesthesie u. Intensivmedizin
  • LKH Salzburg, St. Johanns-Spital
  • Univ.-Klinik f. Notfallmedizin
  • Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
  • AZ Sint-Jan AV
  • CHU Saint-Pierre
  • AZ VUB
  • Cliniques Universitaires Saint-Luc
  • AZ Groeningen
  • CHU de Tivoli
  • Universitaire Ziekenhuizen Leuven
  • CHR de la Citadelle
  • CHR de Namur
  • Hôpital Jean Minjoz
  • Hôpital Avicenne
  • Hôpital Henri Mondor
  • Hôpital André Mignot
  • Hôpital Régional et Universitaire
  • Hôpital Marc Jacquet
  • Hôpital Lapeyronie
  • Hôpital Necker
  • Hôpital Charles Nicolle
  • Hôpital Purpan
  • Hôpital Pierre Bazin
  • Universitätsklinikum Benjamin Franklin
  • Humboldt-Klinikum
  • DRK Kliniken Westend
  • Städtische Kliniken Bielefeld gem. GmbH
  • Klinikum der Ruhr-Universität Bochum
  • Knappschaftskrankenhaus Dortmund
  • Chirurgische Universität Freiburg
  • Georg-August Universität Göttingen
  • Martin-Luther-Universität Halle
  • Universität Heidelberg
  • Friedrich-Schiller Universität Jena
  • Universitätsklinikum Schleswig-Holstein
  • Berufsfeuerwehr Kiel
  • Universitätsklinikum Mannheim
  • Klinikum rechts der Isar
  • Klinikum Saarbrücken gGmbH
  • Universitätsklinikum Ulm
  • A. O. Ospedali Riuniti di Bergamo
  • Ospedale S. Anna
  • A. O. Universitaria S. Martino
  • A. O. San Gerardo di Monza
  • Policlinico S. Matteo
  • Osp. di Circolo Fondazione Macchi
  • ICU, Haukeland Universitetssykehus
  • ICU, Sykehuset Østfold Fredrikstad
  • Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
  • Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
  • Hospital de Torrecárdenas / ICU
  • Hospital Clínico Provincial de BCN / Cardiology Service
  • Hospital Universitario Reina Sofía / ICU
  • Vírgen de las Nieves. Critical Care-Emergency Room
  • Hospital de Jerez de la Frontera / ICU
  • Hospital Clínico San Carlos / Hemodynamics
  • Hospital Clínico Universitario Vírgen de la Victoria / ICU
  • Boehringer Ingelheim Investigational Site
  • Complejo Hospitalario Universitario de Vigo / Cardiology
  • Hospital Clinico Univ. Lozano Blesa
  • Anestesikliniken
  • Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
  • Södersjukhuset
  • Universitetssjukhuset
  • Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Return of spontaneous circulation (ROSC)
24-hr survival
Neurological and overall outcome at hospital discharge or at day 30, whichever came first
Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first
Major bleeds up to hospital discharge or day 30, whichever came first

Full Information

First Posted
September 8, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00157261
Brief Title
Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2006 (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1050 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tenecteplase
Primary Outcome Measure Information:
Title
The primary endpoint of this study is the 30-day survival rate
Time Frame
30 days
Title
The co-primary endpoint of this study is hospital admission
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Return of spontaneous circulation (ROSC)
Time Frame
30 days
Title
24-hr survival
Time Frame
24 hours
Title
Neurological and overall outcome at hospital discharge or at day 30, whichever came first
Time Frame
30 days
Title
Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first
Time Frame
30 days
Title
Major bleeds up to hospital discharge or day 30, whichever came first
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Univ.-Klinik f. Anaesthesie Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Univ.-Klinik f. Anaesthesie u. Intensivmedizin
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
LKH Salzburg, St. Johanns-Spital
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Univ.-Klinik f. Notfallmedizin
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint-Jan AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
AZ VUB
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Groeningen
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHR de Namur
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Hôpital Jean Minjoz
City
Besançon cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hôpital Régional et Universitaire
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Marc Jacquet
City
Melun cedex
ZIP/Postal Code
77011
Country
France
Facility Name
Hôpital Lapeyronie
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Necker
City
Paris cedex 15
ZIP/Postal Code
75743
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Hôpital Purpan
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Pierre Bazin
City
Voiron cedex
ZIP/Postal Code
38506
Country
France
Facility Name
Universitätsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Humboldt-Klinikum
City
Berlin
ZIP/Postal Code
13504
Country
Germany
Facility Name
DRK Kliniken Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Städtische Kliniken Bielefeld gem. GmbH
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Klinikum der Ruhr-Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Knappschaftskrankenhaus Dortmund
City
Dortmund
ZIP/Postal Code
44309
Country
Germany
Facility Name
Chirurgische Universität Freiburg
City
Freiburg/Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Georg-August Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Martin-Luther-Universität Halle
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Friedrich-Schiller Universität Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Berufsfeuerwehr Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68168
Country
Germany
Facility Name
Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Saarbrücken gGmbH
City
Saarbrücken
ZIP/Postal Code
66119
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
A. O. Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Ospedale S. Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
A. O. Universitaria S. Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A. O. San Gerardo di Monza
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Osp. di Circolo Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
ICU, Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
ICU, Sykehuset Østfold Fredrikstad
City
Fredrikstad
ZIP/Postal Code
N-1603
Country
Norway
Facility Name
Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
City
Stavanger
ZIP/Postal Code
N-4068
Country
Norway
Facility Name
Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
City
Tønsberg
ZIP/Postal Code
N-3101
Country
Norway
Facility Name
Hospital de Torrecárdenas / ICU
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Clínico Provincial de BCN / Cardiology Service
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofía / ICU
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Vírgen de las Nieves. Critical Care-Emergency Room
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hospital de Jerez de la Frontera / ICU
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Clínico San Carlos / Hemodynamics
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico Universitario Vírgen de la Victoria / ICU
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo / Cardiology
City
Vigo
ZIP/Postal Code
36214
Country
Spain
Facility Name
Hospital Clinico Univ. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Anestesikliniken
City
Gävle
ZIP/Postal Code
807 87
Country
Sweden
Facility Name
Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Universitetssjukhuset
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
City
Lausanne
ZIP/Postal Code
1005
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19092151
Citation
Bottiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.18_U10-1036.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.18_statement.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.18_literature.pdf
Description
Related Info

Learn more about this trial

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

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