A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979704
• Other study ID #: No.BSMMU/2016/8307
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 31, 2016
• Last updated: December 1, 2016
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Samia Tonu, MBBS
• Phone: +8801769350011
• Email: tonusamia[@]gmail.com
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Rosuvastatin
45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks
• Atorvastatin
45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks

Locations

Country	Name	City	State
Bangladesh	BSMMU	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

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