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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00157261 |
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.
Condition | Intervention | Phase |
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Heart Arrest |
Drug: tenecteplase |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Arre |
Estimated Enrollment: | 1300 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients, indicated for pre-hospital ALS-CPR procedures* must fulfil the following inclusion criteria:
Subjects who meet any of the following criteria will be excluded from randomisation into the study:
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
Study ID Numbers: | 1123.18 |
Study First Received: | September 8, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00157261 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Austria: Federal Ministry for Health and Women; Belgium: Ministry of Social Affairs, Public Health and the Environment; France: Haute Autorité de Santé Transparency Commission; Germany: German Institute of Medical Documentation and Information; Italy: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic |
Fibrin Modulating Agents Heart Diseases Tenecteplase |
Fibrinolytic Agents Heart Arrest Cardiovascular Agents |
Fibrin Modulating Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents Tenecteplase |
Fibrinolytic Agents Cardiovascular Diseases Heart Arrest Cardiovascular Agents Pharmacologic Actions |