Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
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|
- 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 ]
- 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 ]
|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)|
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157261
Show 68 Study Locations
|Study Chair:||Boehringer Ingelheim Study Coordinator||B.I. Pharma GmbH & Co. KG|