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Heart ArrestPhase 3NCT00157261

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

A Phase 3 study testing tenecteplase in people with Heart Arrest, run by Boehringer Ingelheim at 68 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Arrest
What is being tested?
tenecteplase
How many people
1,050 participants
Where
68 sitesin 9 countries
Study dates
Jan 2004to Jun 2006
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

68 sites in 9 countries.

68 sites in 9 countries

Germany17 sites

  • Universitätsklinikum Benjamin Franklin

    Berlin, 12200

  • Humboldt-Klinikum

    Berlin, 13504

  • DRK Kliniken Westend

    Berlin, 14050

  • Städtische Kliniken Bielefeld gem. GmbH

    Bielefeld, 33604

  • Klinikum der Ruhr-Universität Bochum

    Bochum, 44791

  • Knappschaftskrankenhaus Dortmund

    Dortmund, 44309

  • Chirurgische Universität Freiburg

    Freiburg/Breisgau, 79106

  • Georg-August Universität Göttingen

    Göttingen, 37075

  • Martin-Luther-Universität Halle

    Halle, 06120

  • Universität Heidelberg

    Heidelberg, 69120

  • Friedrich-Schiller Universität Jena

    Jena, 07740

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Berufsfeuerwehr Kiel

    Kiel, 24116

  • Universitätsklinikum Mannheim

    Mannheim, 68168

  • Klinikum rechts der Isar

    München, 81675

  • Klinikum Saarbrücken gGmbH

    Saarbrücken, 66119

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

France11 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital André Mignot

    Le Chesnay, 78150

  • Hôpital Régional et Universitaire

    Lille, 59037

  • Hôpital Marc Jacquet

    Melun, 77011

  • Hôpital Lapeyronie

    Montpellier, 34295

  • Hôpital Necker

    Paris, 75743

  • Hôpital Charles Nicolle

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31059

  • Hôpital Pierre Bazin

    Voiron, 38506

Other trials in France

Belgium10 sites

  • Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan AV

    Bruges, 8000

  • CHU Saint-Pierre

    Brussels, 1000

  • AZ VUB

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeningen

    Kortrijk, 8500

  • CHU de Tivoli

    La Louvière, 7100

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

  • CHR de la Citadelle

    Liège, 4000

  • CHR de Namur

    Namur, 5000

Other trials in Belgium

Spain10 sites

  • Hospital de Torrecárdenas / ICU

    Almería, 04009

  • Hospital Clínico Provincial de BCN / Cardiology Service

    Barcelona, 08036

  • Hospital Universitario Reina Sofía / ICU

    Córdoba, 14004

  • Vírgen de las Nieves. Critical Care-Emergency Room

    Granada, 18012

  • Hospital de Jerez de la Frontera / ICU

    Jerez de la Frontera, 11407

  • Hospital Clínico San Carlos / Hemodynamics

    Madrid, 28040

  • Hospital Clínico Universitario Vírgen de la Victoria / ICU

    Málaga, 29010

  • Boehringer Ingelheim Investigational Site

    Seville, 41014

  • Complejo Hospitalario Universitario de Vigo / Cardiology

    Vigo, 36214

  • Hospital Clinico Univ. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Italy6 sites

  • A. O. Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • Ospedale S. Anna

    Como, 22100

  • A. O. Universitaria S. Martino

    Genova, 16132

  • A. O. San Gerardo di Monza

    Monza, 20052

  • Policlinico S. Matteo

    Pavia, 27100

  • Osp. di Circolo Fondazione Macchi

    Varese, 21100

Other trials in Italy

Austria4 sites

  • Univ.-Klinik f. Anaesthesie Graz

    Graz, 8036

  • Univ.-Klinik f. Anaesthesie u. Intensivmedizin

    Innsbruck, 6020

  • LKH Salzburg, St. Johanns-Spital

    Salzburg, 5020

  • Univ.-Klinik f. Notfallmedizin

    Vienna, 1090

Other trials in Austria

Norway4 sites

  • ICU, Haukeland Universitetssykehus

    Bergen, N-5021

  • ICU, Sykehuset Østfold Fredrikstad

    Fredrikstad, N-1603

  • Akuttklinikken / NLA, Sentralsjukehuset i Rogaland

    Stavanger, N-4068

  • Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg

    Tønsberg, N-3101

Other trials in Norway

Sweden4 sites

  • Anestesikliniken

    Gävle, 807 87

  • Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg

    Gothenburg, 413 45

  • Universitetssjukhuset

    Örebro, 701 85

  • Södersjukhuset

    Stockholm, 118 83

Other trials in Sweden

Switzerland2 sites

  • Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429

    Lausanne, 1005

  • Boehringer Ingelheim Investigational Site

    Lugano, 6900

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Heart Arrest
Being tested
tenecteplase
Medical subject headings
Heart Arrest

What participants receive

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

  • tenecteplaseDrug

What is being measured

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

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

    Measured: 30 days

  2. The co-primary endpoint of this study is hospital admission

    Measured: 30 days

Secondary outcomes (5)

  1. Return of spontaneous circulation (ROSC)

    Measured: 30 days

  2. 24-hr survival

    Measured: 24 hours

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

    Measured: 30 days

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

    Measured: 30 days

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

    Measured: 30 days

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionJun 2006
  4. Study completionJun 2006

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
Double blind
Enrolment
1,050 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157261
Sponsor's protocol ID
1123.18
Status last verified
Oct 2013
First submitted
8 Sep 2005
Last updated
29 Oct 2013
Results posted
No

Publications

  • 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.

    PubMed 19092151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tenecteplase in people with Heart Arrest, run by Boehringer Ingelheim at 68 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Germany, France, Belgium, Spain, Italy and 4 more countries. 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 was stopped early. Results are not available in the source record.

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?

The primary endpoint of this study is the 30-day survival rate (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT00157261, which also lists 1 linked publication.

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 29 Oct 2013.

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