Hyperlipidemia Clinical Trial
Official title:
Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia
This study will be conducted to assess the status of oxidative stress inflammation and thrombogenesis in patients with hyperlipidemia and to compare the antioxidative, anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | July 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion criteria: - Age from (20-75) yrs, both male and female having LDL cholesterol: 160-190 mg/dl, triglyceride (TG): 200-499 mg/dl will be recruited in the study Exclusion criteria: - Patients age <25 years or >75 years - Patients are on lipid lowering medications - Patients taking omega-3 fatty acid or garlic - Patients with history of hypersensitivity on any member of statin - Patients taking anti-inflammatory medications (steroid or NSAIDS) - Patients taking antioxidant vitamins (vitamin A, C, E) - Patients with impaired renal function - Patients with impaired liver function - Pregnant women and nursing mother - Patients having serious infections or terminal illness |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bangladesh | BSMMU | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia | Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L | [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] | No |
Primary | Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia | Reduction of inflammation will be measured by change in level of hs-CRP in mg/L | [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] | No |
Primary | Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia | Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood | [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] | No |
Primary | Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia | Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec | [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] | No |
Primary | Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia | Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb | [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] | No |
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