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

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00157261
First received: September 8, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Heart Arrest
Drug: tenecteplase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint of this study is the 30-day survival rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The co-primary endpoint of this study is hospital admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return of spontaneous circulation (ROSC) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 24-hr survival [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Neurological and overall outcome at hospital discharge or at day 30, whichever came first [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major bleeds up to hospital discharge or day 30, whichever came first [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: January 2004
Estimated Study Completion Date: June 2006
Estimated Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157261

  Show 68 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00157261     History of Changes
Other Study ID Numbers: 1123.18
Study First Received: September 8, 2005
Last Updated: October 28, 2013
Health Authority: Sweden: Medical Products Agency
Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
France: Haute Autorité de Santé Transparency Commission
Germany: German Institute of Medical Documentation and Information
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Tenecteplase
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 22, 2014