A Prospective, Randomized, Parallel, Double-Blind, Clinical Trial to Assess the Efficacy of Rosuvastatin in Subclinical Atherosclerosis Patients (Rose Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The ROSE Trial is a prospective, randomized, double blind, parallel group, investigator initiated study designed to evaluate the efficacy of Rosuvastatin, 20 milligrams daily, in patients with subclinical atherosclerosis. The study will be conducted at Apollo Rajshree Hospitals in Indore and will enroll 160 adults aged between thirty and seventy-five years with mild to moderate atherosclerotic changes. These changes are defined as carotid intima-media thickness of greater than 0.9 millimeters, coronary artery calcium score of less than 300, and luminal stenosis of less than 70 percent, but without a history of cardiovascular disease. Eligible participants will be randomized in a one-to-one ratio to receive Rosuvastatin or standard of care. The primary endpoints include changes in carotid intima-media thickness, plaque volume, peak systolic velocity, and luminal stenosis. Secondary endpoints include changes in lipid profile, high-sensitivity C-reactive protein, and coronary artery calcium scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 0 and 6 Months (Pre and Post Intervention)
2.Change in Plaque Volume: Carotid Doppler will be employed to measure plaque volume, reported in cubic millimeters (mm³).
时间窗: 0 and 6 Months (Pre and Post Intervention)
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.
时间窗: 0 and 6 Months (Pre and Post Intervention)
4.Change in Peak Systolic Velocity: Ultrasonography
时间窗: 0 and 6 Months (Pre and Post Intervention)
次要结局
- 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)