Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02979704
Other study ID # No.BSMMU/2016/8307
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02927184 - Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Phase 2
Completed NCT04640012 - Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects Phase 1
Completed NCT03213288 - Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status N/A
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Completed NCT02569814 - A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin Phase 1
Completed NCT02428998 - Safety for 24 Weeks Intake of Korean Red Ginseng in Adults N/A
Completed NCT02280590 - Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia Phase 4
Completed NCT01678183 - Financial Incentives for Medication Adherence N/A
Completed NCT01426412 - A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol Phase 1
Completed NCT01694446 - Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose N/A
Completed NCT01131832 - Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols Phase 4
Completed NCT00758303 - A Study to Evaluate the Lipid Regulating Effects of TRIA-662 Phase 2/Phase 3
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00408824 - Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study) N/A
Terminated NCT00299169 - Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes Phase 4
Completed NCT00362206 - Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin Phase 3
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A
Completed NCT00414986 - Using Learning Teams for Reflective Adaptation for Diabetes and Depression N/A
Completed NCT00701454 - Survey of Thai-Muslim Health Status N/A