HyperlipidemiaPhase 2/3NCT02979704
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
A Phase 2/3 study testing Rosuvastatin and Atorvastatin in people with Hyperlipidemia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Rosuvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2016to Jul 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Patients with impaired renal function
- Patients with impaired liver function
- Pregnant women and nursing mother
- Patients having serious infections or terminal illness
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka
Samia Tonu, MBBS, +8801769350011, tonusamia@gmail.com
Nargis Akhter, Mphill, MSc, +880152391036, nargisakhter@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Rosuvastatin, Atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rocovas
45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks
AtorvastatinDrug
Also called Tiginor
45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | Intervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks. Receives: Drug: Rosuvastatin |
| Atorvastatin | Active comparator | Intervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
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
Measured: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
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
Measured: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
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
Measured: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
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
Measured: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Haque Tonu, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Samia Tonu, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979704
- Sponsor's protocol ID
- No.BSMMU/2016/8307
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02979704
- Acronym / sponsor ID
- No.BSMMU/2016/8307
- Conditions
- Hyperlipidemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: RosuvastatinIntervention: Tablet Rosuvastatin (5-10) mg orally once daily dose for 08 weeks. |
| Atorvastatin | Active comparator | Drug: AtorvastatinIntervention: Tablet Atorvastatin (10-20) mg orally once daily dose for 08 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Rocovas45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks | Drug | Rosuvastatin |
| AtorvastatinAlso: Tiginor45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks | Drug | Atorvastatin |
Primary outcome
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia Tonu, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rosuvastatin and Atorvastatin in people with Hyperlipidemia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samia Tonu, MBBS (+8801769350011, tonusamia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.