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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resus

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 Summary:

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.


Sponsor: Boehringer Ingelheim

Current Primary Outcome:

  • The primary endpoint of this study is the 30-day survival rate [ Time Frame: 30 days ]
  • The co-primary endpoint of this study is hospital admission [ Time Frame: 30 days ]


Original Primary Outcome: The primary endpoint of this study is the 30-day survival rate. The co-primary endpoint of this study is hospital admission.

Current Secondary Outcome:

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


Original Secondary Outcome: Return of spontaneous circulation, 24-hr survival, survival to hospital discharge or day 30 whichever is first, distribution of neurological and overall outcome scores.

Information By: Boehringer Ingelheim

Dates:
Date Received: September 8, 2005
Date Started: January 2004
Date Completion: June 2006
Last Updated: October 28, 2013
Last Verified: October 2013