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

Heart Arrest Clinical 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157261
• Other study ID #: 1123.18
• Status: Terminated
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 28, 2013
• Start date: January 2004
• Est. completion date: June 2006

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyAustria: Federal Ministry for Health and WomenBelgium: Ministry of Social Affairs, Public Health and the EnvironmentFrance: Haute Autorité de Santé Transparency CommissionGermany: German Institute of Medical Documentation and InformationItaly: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencySpain: Spanish Agency of MedicinesSwitzerland: Swissmedic
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1050
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Drug:
• tenecteplase

Locations

Country	Name	City	State
Austria	Univ.-Klinik f. Anaesthesie Graz	Graz
Austria	Univ.-Klinik f. Anaesthesie u. Intensivmedizin	Innsbruck
Austria	LKH Salzburg, St. Johanns-Spital	Salzburg
Austria	Univ.-Klinik f. Notfallmedizin	Wien
Belgium	Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg	Antwerpen
Belgium	AZ Sint-Jan AV	Brugge
Belgium	AZ VUB	Bruxelles
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	AZ Groeningen	Kortrijk
Belgium	CHU de Tivoli	La Louvière
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Belgium	CHR de la Citadelle	Liège
Belgium	CHR de Namur	Namur
France	Hôpital Jean Minjoz	Besançon cedex
France	Hôpital Avicenne	Bobigny cedex
France	Hôpital Henri Mondor	Creteil cedex
France	Hôpital André Mignot	Le Chesnay
France	Hôpital Régional et Universitaire	Lille cedex
France	Hôpital Marc Jacquet	Melun cedex
France	Hôpital Lapeyronie	Montpellier cedex 5
France	Hôpital Necker	Paris cedex 15
France	Hôpital Charles Nicolle	Rouen cedex
France	Hôpital Purpan	Toulouse cedex
France	Hôpital Pierre Bazin	Voiron cedex
Germany	DRK Kliniken Westend	Berlin
Germany	Humboldt-Klinikum	Berlin
Germany	Universitätsklinikum Benjamin Franklin	Berlin
Germany	Städtische Kliniken Bielefeld gem. GmbH	Bielefeld
Germany	Klinikum der Ruhr-Universität Bochum	Bochum
Germany	Knappschaftskrankenhaus Dortmund	Dortmund
Germany	Chirurgische Universität Freiburg	Freiburg/Breisgau
Germany	Georg-August Universität Göttingen	Göttingen
Germany	Martin-Luther-Universität Halle	Halle/Saale
Germany	Universität Heidelberg	Heidelberg
Germany	Friedrich-Schiller Universität Jena	Jena
Germany	Berufsfeuerwehr Kiel	Kiel
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Klinikum rechts der Isar	München
Germany	Klinikum Saarbrücken gGmbH	Saarbrücken
Germany	Universitätsklinikum Ulm	Ulm
Italy	A. O. Ospedali Riuniti di Bergamo	Bergamo
Italy	Ospedale S. Anna	Como
Italy	A. O. Universitaria S. Martino	Genova
Italy	A. O. San Gerardo di Monza	Monza
Italy	Policlinico S. Matteo	Pavia
Italy	Osp. di Circolo Fondazione Macchi	Varese
Norway	ICU, Haukeland Universitetssykehus	Bergen
Norway	ICU, Sykehuset Østfold Fredrikstad	Fredrikstad
Norway	Akuttklinikken / NLA, Sentralsjukehuset i Rogaland	Stavanger
Norway	Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg	Tønsberg
Spain	Hospital de Torrecárdenas / ICU	Almería
Spain	Hospital Clínico Provincial de BCN / Cardiology Service	Barcelona
Spain	Hospital Universitario Reina Sofía / ICU	Cordoba
Spain	Vírgen de las Nieves. Critical Care-Emergency Room	Granada
Spain	Hospital de Jerez de la Frontera / ICU	Jerez de la Frontera
Spain	Hospital Clínico San Carlos / Hemodynamics	Madrid
Spain	Hospital Clínico Universitario Vírgen de la Victoria / ICU	Malaga
Spain	Boehringer Ingelheim Investigational Site	Sevilla
Spain	Complejo Hospitalario Universitario de Vigo / Cardiology	Vigo
Spain	Hospital Clinico Univ. Lozano Blesa	Zaragoza
Sweden	Anestesikliniken	Gävle
Sweden	Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg	Göteborg
Sweden	Universitetssjukhuset	Örebro
Sweden	Södersjukhuset	Stockholm
Switzerland	Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429	Lausanne
Switzerland	Boehringer Ingelheim Investigational Site	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the 30-day survival rate		30 days	No
Primary	The co-primary endpoint of this study is hospital admission		30 days	No
Secondary	Return of spontaneous circulation (ROSC)		30 days	No
Secondary	24-hr survival		24 hours	No
Secondary	Neurological and overall outcome at hospital discharge or at day 30, whichever came first		30 days	No
Secondary	Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first		30 days	No
Secondary	Major bleeds up to hospital discharge or day 30, whichever came first		30 days	No

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