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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00157261
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
• Scientific 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
• Date of first enrolment: January 2004
• Target sample size: 1050
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00157261
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland

Contacts

• Name: Boehringer Ingelheim Study Coordinator
• Affiliation: B.I. Pharma GmbH & Co. KG

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Arrest

Intervention(s)

Drug: tenecteplase

Primary Outcome(s)

The co-primary endpoint of this study is hospital admission [Time Frame: 30 days]

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

Secondary Outcome(s)

Return of spontaneous circulation (ROSC) [Time Frame: 30 days]

24-hr survival [Time Frame: 24 hours]

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]

Neurological and overall outcome at hospital discharge or at day 30, whichever came first [Time Frame: 30 days]

Secondary ID(s)

1123.18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors