Status
Conditions
Treatments
About
The purpose of this investigation is to compare subjects at high risk for silent myocardial ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the ranolazine group to determine if ranolazine can be used as a treatment to decrease silent myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined in this protocol as diabetics with stable ischemic heart disease. This study will look at the impact ranolazine treatment has on biomarkers that have been shown to be highly associated with increased risk of morbidity and mortality in relation to SMI. If the hypothesis is correct, further studies can be conducted to determine if treatment with ranolazine has impact on long-term outcomes such as hospitalizations, myocardial infarction, congestive heart failure or sudden cardiac death.
Sex
Ages
Volunteers
Inclusion criteria
Subjects at risk for silent myocardial ischemia as defined by:
Stable ischemic heart disease as defined by:
Type 2 diabetics as defined by:
HgbA1C ≥ 6.5 percent, or
Fasting Blood Glucose > 125 mg/dL on two or more blood draws, or
Random Blood Glucose of ≥ 200 mg/dL on a single blood draw, or
Previous diagnosis of type 2 diabetes listed in the subject's medical record AND
Beta Blocker
Aspirin
Statin AND
Females < 60 who have not been free of menstruation for 2 years (menopause diagnosed) or who do not have documented history of hysterectomy must be willing to use at least one form of birth control (including abstinence as an option) for the duration of the study. If condoms are the method chosen, they are strongly urged to use a second form of birth control in addition to condoms.
AND
Screening Criteria met:
• hs cTnT > 0.014 ng/mL
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal