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

Phase 3

Terminated

• Conditions: Heart Arrest

• Registration Number: NCT00157261
• Lead Sponsor: Boehringer Ingelheim

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (67)

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, Austria

Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg; 🇧🇪 Antwerpen, Belgium

AZ Sint-Jan AV; 🇧🇪 Brugge, Belgium

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium

AZ VUB; 🇧🇪 Bruxelles, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

AZ Groeningen; 🇧🇪 Kortrijk, Belgium

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