Clinical trial NCT02979704: A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
Official title: Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Hyperlipidemia is the major risk factor for development of atherosclerosis which ultimately leads to cardiovascular disease (CVD), an important cause of mortality and morbidity worldwide. Atherosclerosis was previously considered as a lipid storage disease but now growing evidence indicates that increased oxidative stress, vascular inflammation and platelet activation play an important role in the initiation and progression of atherosclerosis. Among the hypolipidemic drugs, statins, 3-hydroxyl-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, have proved to be very much effective. Therefore, statins are the most widely used hypolipidemic agents. Evidence shows that besides hypolipidemic action statins possess antioxidative, anti-inflammatory and antithrombogenic effects known as pleiotropic action which might play an important role in attenuating the atherosclerotic process. However, pleiotropic effect varies with different members of statins.

The present prospective interventional study would be conducted in the Department of Pharmacology, Department of Cardiology and Internal Medicine, BSMMU from March 2016 to August 2017. Total 90 cases will be selected according to inclusion and exclusion criteria. The cases will be subdivided into 2 groups: group A and B. Group A consisting of 45 patients who will receive rosuvastatin (5-10) mg orally once daily and Group B consisting of 45 patients who will receive atorvastatin (10-20) mg orally once daily for 08 weeks. Patient's blood sample will be collected to measure baseline lipid profile, malondialdehyde (MDA), erythrocytic glutathione (GSH), high sensitive C-reactive protein (hs-CRP), prothrombin time (PT), platelet count. After obtaining baseline data patients will be assigned to the respective group. Parameters of baseline will again be evaluated after 08 weeks of therapeutic intervention. Regularity of drug intake will be ensured over telephone, pill count, and from the patient's compliance sheet. Patient's data will be recorded in a predetermined data sheet. Patients will be informed about study, its merits and demerits in easy language and then informed consent will be taken.Therefore, the present study has been designed to compare the antioxidative, anti-inflammatory and antithrombogenic effects of rosuvastatin and atorvastatin in hyperlipidemic patients to establish the superiority of a particular statin, so that it will provide a better therapeutic option in order to prevent CVD related mortality and morbidity.

Eligibility criteria: 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

Primary outcomes:
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia
timeFrame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia
timeFrame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
measure: Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia
timeFrame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
measure: Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia
timeFrame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
measure: Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia
timeFrame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMU
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Samia Tonu, MBBS
role: PRINCIPAL_INVESTIGATOR
References: