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A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979704
Recruitment Status : Unknown
Verified August 2016 by Samia Haque Tonu, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Recruitment status was:  Recruiting
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Samia Haque Tonu, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Rosuvastatin Drug: Atorvastatin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia
Study Start Date : September 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rosuvastatin
Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks.
Drug: Rosuvastatin
45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks
Other Name: Rocovas

Active Comparator: Atorvastatin
Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks
Drug: Atorvastatin
45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks
Other Name: Tiginor




Primary Outcome Measures :
  1. Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia [ Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] ]
    Reduction of oxidative stress will be measured by changes in level of MDA in µmol/L

  2. Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia [ Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] ]
    Reduction of inflammation will be measured by change in level of hs-CRP in mg/L

  3. Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia [ Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] ]
    Reduction of thrombogenesis will be measured by changes in level of platelet count in per L of blood

  4. Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia [ Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] ]
    Reduction of thrombogenesis will be measured by changes in level of prothrombin time in per sec

  5. Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia [ Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No] ]
    Reduction of oxidative stress will be measured by changes in level of erythrocytic GSH in mg/gm of Hb



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979704


Contacts
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Contact: Samia Tonu, MBBS +8801769350011 tonusamia@gmail.com
Contact: Nargis Akhter, Mphill, Msc +8801552391036 nargisakhter@hotmail.com

Locations
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Bangladesh
BSMMU Recruiting
Dhaka, Bangladesh
Contact: Samia Tonu, MBBS    +8801769350011    tonusamia@gmail.com   
Contact: Nargis Akhter, Mphill, MSc    +880152391036    nargisakhter@hotmail.com   
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: Samia Tonu, MBBS BSMMU

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Responsible Party: Samia Haque Tonu, Dr. and MD resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT02979704    
Other Study ID Numbers: No.BSMMU/2016/8307
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors