Subjects with coronary artery disease or left ventricular dysfunction experiencing an acute coronary syndrome with non-life-threatening ventricular arrhythmias.
Conditions
Interventions
Product Name: GAP-486
Product Code: ZP123
Pharmaceutical Form: Injection*
INN or Proposed INN: Not Available
CAS Number: Not Assigned
Current Sponsor code: GAP-486
Other descriptive name: WAY-214486
C
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Men and surgically sterile or postmenopausal women of legal consenting age. -Subjects must fulfill clinical criteria for an acute ischemic event -Subjects must have documented coronary artery disease or left ventricular (LV) dysfunction -Subjects must have experienced at least 1 episode of non-sustained ventricular tachycardia (NSVT) before the 3-hour baseline Holter monitor is started Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects for whom percutaneous coronary intervention (PCI), thrombolytics, or CABG is anticipated during the 24-hour on-therapy phase of the study. Revascularization procedures must not be delayed or withheld for the purposes of qualifying for or participating in the study. -Subjects who have had previous PCI, treatment with thrombolytics, CABG, or other cardiac surgeries within 48 hours prior to screening. -Any antiarrhythmics (with the exception of beta blockers) given within 5 half-lives of the start of the 24-hour on-therapy phase of the study. -Subjects with cardiogenic shock -Subjects with acute pulmonary edema. -Documented history of torsade de pointes. -Known congenital long QT syndrome. -QTc > 0.50 second at screening. -Bradycardia 1 minute or sinus pauses > 3 seconds while awake which occur anytime during the 30 minutes prior to test article administration. -Subjects with New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF). -Presence of or immediate need for continuous ventricular demand pacemaker. -Known significant hepatic dysfunction unrelated to the acute ischemic event or renal dysfunction -Subjects with hypokalemia at the time of Holter monitor placement. -Subjects with new onset atrial fibrillation of 1 month and has been receiving anticoagulants for > 1 month, and meets all the inclusion/exclusion criteria, they are eligible to participate in the study. -Current use of investigational device or use of investigational drug within 30 days before entry into the study. -Subject who previously received test article in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that administration of GAP-486 is effective in decreasing the number of non-life-threatening ventricular arrhythmias in subjects who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction [STEMI] or myocardial infarction without ST elevation [NSTEMI] subjects).;Secondary Objective: To assess safety and tolerability in subjects with acute coronary syndrome.To assess the dose-range and identify potentially effective doses for phase 3 studies.;Primary end point(s): Total number of ventricular arrhythmia beats (the sum of ventricular arrhythmia beats from premature ventricular contractions, couplets, and individual beats in each NSVT and sustained VT episode [see section 6.0 of the Protocol for definitions]) recorded by Holter monitoring during the 24-hour on-therapy phase. | — |
Countries
Denmark, Hungary, Sweden, United Kingdom
Outcome results
None listed