A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)
- NCT00168792
- PHASE4
- INTERVENTIONAL
Last updated: 2013-10-29
Purpose of Trial
To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.
This study is for people with
Myocardial Infarction
Interventions being studied
Tenecteplase
PCI
Inclusion Criteria:
* Patients giving informed consent
* Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset
* Patients scheduled to undergo primary PCI
* Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation
(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)
Exclusion Criteria: None
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
8 Locations
Little Rock
Boehringer Ingelheim Investigational Site
Arkansas, United States
Fort Lauderdale
Boehringer Ingelheim Investigational Site
Florida, United States
St. Petersburg
Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
Boehringer Ingelheim Investigational Site
Florida, United States
Macan
Boehringer Ingelheim Investigational Site
Georgia, United States
Detroit
Boehringer Ingelheim Investigational Site
Michigan, United States
Omaha
Boehringer Ingelheim Investigational Site
Nebraska, United States
Providence
Boehringer Ingelheim Investigational Site
Rhode Island, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov