Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
Intervention1: Rosuvastatin: 20 mg, OD, 6 months
Control Intervention1: Standard of Care: Rosuvastatin will not be provided in this arm
Sponsors
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females between 30 and 75 years of age capable and willing to provide informed consent 2.Participant with sub-clinical atherosclerosis (mild to moderate) defined as plaque visible on Carotid Doppler and causing less than 70% luminal stenosis, and CIMT less than 0.9 mm. 3.Fasting LDL C of greater than or equal to 100 mg/dL (3.1 mmol/L), Triglycerides less than 500 mg/dL (5.65 mmol/L), HDL-C levels less than or equal to 60 mg/dL (1.6 mmol/L)
Exclusion criteria
Exclusion criteria: 1.Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease 2.Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome) 3.Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of greater than or equal to 110 mmHg or a resting systolic blood pressure of greater than or equal to 180 mmHg recorded at any time during the screening period 4.Diabetes patients 5.Thyroid replacement therapy 6.History of familial hypercholesterolemia 7.Participant with estimated glomerular filtration rate less than 60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal 8.Patient with a history of an allergic reaction or significant sensitivity to statins 9.Patient currently taking LDL cholesterol lowering or anti-inflammatory medications including colchicine 10.Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin) 11.A female patient who is pregnant, breast-feeding or considering becoming pregnant during the study 12.Participant with BMI greater than or equal to 40 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Carotid Intima-Media Thickness (CIMT) Measurements: Ultrasonography will assess CIMT, reported in millimeters (mm) compared to treatment arm and Standard of Care. 2.Change in Plaque Volume: Carotid Doppler will be employed to measure plaque volume, reported in cubic millimeters (mm ). 3.Change in Maximal Luminal Stenosis: The maximal luminal stenosis, expressed as a percentage, will be assessed to determine the degree of coronary artery narrowing using Carotid doppler. 4.Change in Peak Systolic Velocity: UltrasonographyTimepoint: 0 and 6 Months (Pre and Post Intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in lipid profile such as LDL-C, HDL-C, and Triglyceride Levels 2.Change in High-sensitivity C-Reactive Protein (hs-CRP) levels 3.Change in Calcium score levelsTimepoint: 0 and 6 Months (Pre and Post Intervention) | — |
Countries
India
Contacts
Public ContactDr Achukatla Kumar
Apollo Rajshree Hospitals Indore
Outcome results
None listed