Arrhythmias
Conditions
Keywords
Arrhythmias
Brief summary
To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).
Interventions
DRUGDouble-blind investigational anti-arrhythmic
DRUGGAP-486
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry. * Patients with a documented history of coronary artery disease or left ventricular dysfunction * Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event
Exclusion criteria
* Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration * Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article * Patients who have a history of torsades de pointes, long QT syndrome, QTc \> 0.50
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of NSVT beats, PVCs/couplets, NSVT episodes during the 24 hr. on-therapy phase and incidence of new-onset atrial fibrillation during the 24hr. on-therapy phase. | — |
Countries
Brazil, Canada, Croatia, Denmark, Hungary, India, Italy, Mexico, Poland, Romania, Russia, Serbia, Sweden, Ukraine, United Kingdom, United States
Outcome results
None listed