Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157261
Status:
TERMINATED
Last Update Posted:
2013-10-29
First Post:
2005-09-08
Brief Title:
Thrombolysis Using Tenecteplase Metalyse in Cardiac Arrest - The TROICA Trial
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 ie 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
Comparisons
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
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 ie 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
Comparisons
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None