Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
633
125 mg azimilide, once a day for one year
placebo tablet, once daily for one year
75 mg azimilide, once a day for one year
The Heart Group
Mobile, Alabama, United States
Tri-City Cardiology Consultants, P.C.
Mesa, Arizona, United States
UAMS Dept of Cardiology
Little Rock, Arkansas, United States
ATC/Cardio Medical Grp
Beverly Hills, California, United States
Loma Linda Univ. Med. Ctr.
Loma Linda, California, United States
Reducing the recurrence of all-cause shocks plus symptomatic ATP
Time frame: one year
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Good Samaritan Hospital
Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Regional Cardiology Associates
Sacramento, California, United States
Cardiac Arrythmia Associates
San Diego, California, United States
UCSD Medical Center
San Diego, California, United States
...and 132 more locations