Health Condition 1: null- Coronary artery diseaase with diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of either gender, aged >18 yrs • diagnosed with coronary artery disease (documented by coronary angiography / minimum 3 months history of exertional angina) & diabetes mellitus • HbA1C > 7 % • FPG > 126 mg/dl
Exclusion criteria
Exclusion criteria: ï?? MI in the previous 3 months ï?? NYHA Class IV, Severe valvular heart disease, alcoholic cardiomyopathy, those on pacemakers ï?? Patients on drugs known to prolong QT interval eg. Quinidine, dofetilide, sotalol etc ï?? Anaemia ï?? Hypoxemia ï?? Thyrotoxicosis ï?? Hyper viscosity states ï?? Hyper adrenergic states ï?? Aortic stenosis ï?? Renal failure (serum creatinine 2 mg/dl) ï?? Chronic lung disease ï?? Hepatic failure (Elevated liver enzymes defined as ALT, AST or ALP greater than thrice the upper limit of normal). ï?? Pregnancy or absence of contraceptive use in women of child-bearing age. ï?? Patients receiving CYP 3A4 inhibitors eg. Ketoconazole, Diltiazem, Verapamil, Macrolides, Protease Inhibitors etc ï?? Patients on CYP 3A4 inducers eg. rifampicin, barbiturates etc ï?? Patients taking P-glycoprotein inhibitors eg. verapamil, cyclosporine, digoxin etc ï?? Inability to perform stress ECG test ï?? Baseline ECG abnormalities (e.g. Wolffâ??Parkinsonâ??White syndrome, Bundle Branch Block) ï?? Patients participating in other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study the effect of ranolazine and trimetazidine on HbA1C levels in chronic angina patients with diabetes mellitus. 1. To study the effect of ranolazine and trimetazidine on HbA1C levels in chronic angina patients with diabetes mellitus. 2. To compare the effect of ranolazine and trimetazidine on exercise tolerance in chronic angina patients with diabetes mellitus. Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of ranolazine on Fasting Plasma Glucose (FPG) level in chronic angina patients with concurrent antidiabetic therapy. 2. To find out the need for an increase, decrease or no change in concurrent diabetic therapy in chronic angina patients receiving ranolazine and trimetazidine. 3. To study the effect of ranolazine and trimetazidine on QTc interval in patients with chronic angina. Timepoint: 3 mon | — |
Countries
India
Contacts
JIPMER