Acute Coronary SyndromesPhase 4NCT06765265
Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome
A Phase 4 study testing Rosuvastatin 20 mg/day and Atorvastatin 40 mg in people with Acute Coronary Syndromes, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
there will be 2 groups of patients with acute coronary syndrome. The patients will receive one of the 2 study drugs and impact on raising Vitamin D level will be seen after 6 months Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Rosuvastatin 20 mg/day and Atorvastatin 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2025to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Coronary Syndrome
- 25 OH-Vitamin D levels between 30-70ng/ml
Who cannot join
- Hypercalcemia
- hypocalcemia
- pregnancy
- lactation
- hypersensitivity to statins
- hypothyroidism
- Deranged LFTs \& RFTs
- Use of following within last 3 months (Vitamin D Supplements, lipid lowering drugs, anti-obesity drugs, corticosteroids)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University
Lahore, Punjab Province, 54000
AP Endocrinology, +923004683473, sidrah.lodhi@gmail.com
About this study
there will be 2 groups of patients with acute coronary syndrome. The patients will receive one of the 2 study drugs and impact on raising Vitamin D level will be seen after 6 months
Read the detailed description
this randomized clinical trial will include 152 patients of acute coronary syndrome with normal Vitamin D levels. they will be randomized to receive either Atorvastatin or Rosuvastatin. After 6 months of therapy, the impact on Vitamin D levels will be checked
- Conditions
- Acute Coronary Syndromes
- Being tested
- Rosuvastatin 20 mg/day, Atorvastatin 40 mg
- Keywords
- atorvastatin, rosuvastatin, Vitamin D, Triglyceride, Lipid Profile
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20 mg/dayDrug
Rosuvastatin 20 mg / Day for 24 weeks
Atorvastatin 40 mgDrug
Atorvastatin 40mg / Day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Atorvatstain 40mg OD Receives: Drug: Atorvastatin 40 mg |
| Rosuvastatin | Experimental | Rosuvastatin 20mg Receives: Drug: Rosuvastatin 20 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D
Measured: 24 weeks
Secondary outcomes (1)
Lipid Profile
Measured: 4 weeks & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidrah Lodhi, King Edward Medical University
- Investigators
- Uzma Malik, Study chair, King Edward Medical UniversityAli Hussnain, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765265
- Sponsor's protocol ID
- 508/RC/KEMU/13-11-2023
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Althanoon Z, Faisal IM, Ahmad AA, Merkhan MM, Merkhan MM. Pharmacological aspects of statins are relevant to their structural and physicochemical properties. Systematic Reviews in Pharmacy. 2020 Jul 1;11(7):167-71
Levinson SS. Non-High-Density Lipoprotein Cholesterol and Guidelines for Cholesterol Lowering in Recent History. Lab Med. 2020 Jan 2;51(1):14-23. doi: 10.1093/labmed/lmz032.
PubMed 31147695Sathyapalan T, Shepherd J, Arnett C, Coady AM, Kilpatrick ES, Atkin SL. Atorvastatin increases 25-hydroxy vitamin D concentrations in patients with polycystic ovary syndrome. Clin Chem. 2010 Nov;56(11):1696-700. doi: 10.1373/clinchem.2010.144014. Epub 2010 Sep 3.
PubMed 20817794Thabit A, Alhifany A, Alsheikh R, Namnqani S, Al-Mohammadi A, Elmorsy S, Qari M, Ardawi M. Effect of simvastatin and atorvastatin on serum vitamin d and bone mineral density in hypercholesterolemic patients: a cross-sectional study. J Osteoporos. 2014;2014:468397. doi: 10.1155/2014/468397. Epub 2014 Aug 13.
PubMed 25197610Anagnostis P, Adamidou F, Slavakis A, Polyzos SA, Selalmatzidou D, Panagiotou A, Athyros VG, Karagiannis A, Kita M. Comparative Effect of Atorvastatin and Rosuvastatin on 25-hydroxy-Vitamin D Levels in Non-diabetic Patients with Dyslipidaemia: A Prospective Randomized Open-label Pilot Study. Open Cardiovasc Med J. 2014 Jul 11;8:55-60. doi: 10.2174/1874192401408010055. eCollection 2014.
PubMed 25110531Demir CC, Mousa U, Anil C. Effects of atorvastatin and rosuvastatin therapy on serum 25-hydroxyvitamin D levels: A comparative study 13th European Congress of Endocrinology. Endocr Abstr. 2011;26(1):548.
Bauddh NK, Ranga GS. A study of the effect of rosuvastatin on vitamin D levels in patients with hypertension, diabetes mellitus, and coronary artery disease. Int J Health Sci Res. 2016; 6(7):42-6
Patwardhan VG, Mughal ZM, Padidela R, Chiplonkar SA, Khadilkar VV, Khadilkar AV. To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial. Indian J Pharmacol. 2020 Sep-Oct;52(5):365-371. doi: 10.4103/ijp.IJP_93_18.
PubMed 33283767Jorge AJ, Cordeiro JR, Rosa ML, Bianchi DB. Vitamin D deficiency and cardiovascular diseases. Int J Cardiovas Sci. 2018;31(1):422-32
Sahebkar A, Reiner Z, Simental-Mendia LE, Ferretti G, Della Corte C, Nobili V. Impact of Statin Therapy on Plasma Vitamin D Levels: A Systematic Review and Meta-Analysis. Curr Pharm Des. 2017;23(6):861-869. doi: 10.2174/1381612822666161006150542.
PubMed 27719645Radhakrishnan A, Ruckmani A, Abishek M, Govindaraju S. Statin therapy and Vitamin D. Int J Basic Clin Pharmacol. 2015;4:1113-7.
Bhattacharyya S, Bhattacharyya K, Maitra A. Possible mechanisms of interaction between statins and vitamin D. QJM. 2012 May;105(5):487-91. doi: 10.1093/qjmed/hcs001. Epub 2012 Feb 9. No abstract available.
PubMed 22323613Scragg R. The Vitamin D Assessment (ViDA) study - Design and main findings. J Steroid Biochem Mol Biol. 2020 Apr;198:105562. doi: 10.1016/j.jsbmb.2019.105562. Epub 2019 Dec 3.
PubMed 31809866Verdoia M, Pergolini P, Rolla R, Nardin M, Schaffer A, Barbieri L, Daffara V, Marino P, Bellomo G, Suryapranata H, De Luca G; Novara Atherosclerosis Study Group (NAS). Impact of high-dose statins on vitamin D levels and platelet function in patients with coronary artery disease. Thromb Res. 2017 Feb;150:90-95. doi: 10.1016/j.thromres.2016.12.019. Epub 2016 Dec 28.
PubMed 28068529
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06765265
- Acronym / sponsor ID
- 508/RC/KEMU/13-11-2023
- Conditions
- Acute Coronary Syndromes
- Keywords
- atorvastatin, rosuvastatin, Vitamin D, Triglyceride, Lipid Profile
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- 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.
there will be 2 groups of patients with acute coronary syndrome. The patients will receive one of the 2 study drugs and impact on raising Vitamin D level will be seen after 6 months
Detailed description
this randomized clinical trial will include 152 patients of acute coronary syndrome with normal Vitamin D levels. they will be randomized to receive either Atorvastatin or Rosuvastatin. After 6 months of therapy, the impact on Vitamin D levels will be checked
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin 40 mgAtorvatstain 40mg OD |
| Rosuvastatin | Experimental | Drug: Rosuvastatin 20 mg/dayRosuvastatin 20mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute Coronary Syndrome
- 25 OH-Vitamin D levels between 30-70ng/ml
Key exclusion criteria (8 listed)
- Hypercalcemia
- hypocalcemia
- pregnancy
- lactation
- hypersensitivity to statins
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 |
|---|---|---|
| Rosuvastatin 20 mg/dayRosuvastatin 20 mg / Day for 24 weeks | Drug | Rosuvastatin |
| Atorvastatin 40 mgAtorvastatin 40mg / Day for 24 weeks | Drug | Atorvastatin |
Primary outcome
Serum Vitamin D
Time frame: 24 weeks
1 secondary outcome
Lipid Profile
Time frame: 4 weeks & 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publicationAlthanoon Z, Faisal IM, Ahmad AA, Merkhan MM, Merkhan MM. Pharmacological aspects of statins are relevant to their structural and physicochemical properties. Systematic Reviews in Pharmacy. 2020 Jul 1;11(7):167-71
- Results publication: PubMed 31147695Levinson SS. Non-High-Density Lipoprotein Cholesterol and Guidelines for Cholesterol Lowering in Recent History. Lab Med. 2020 Jan 2;51(1):14-23. doi: 10.1093/labmed/lmz032.
- Results publication: PubMed 20817794Sathyapalan T, Shepherd J, Arnett C, Coady AM, Kilpatrick ES, Atkin SL. Atorvastatin increases 25-hydroxy vitamin D concentrations in patients with polycystic ovary syndrome. Clin Chem. 2010 Nov;56(11):1696-700. doi: 10.1373/clinchem.2010.144014. Epub 2010 Sep 3.
- Results publication: PubMed 25197610Thabit A, Alhifany A, Alsheikh R, Namnqani S, Al-Mohammadi A, Elmorsy S, Qari M, Ardawi M. Effect of simvastatin and atorvastatin on serum vitamin d and bone mineral density in hypercholesterolemic patients: a cross-sectional study. J Osteoporos. 2014;2014:468397. doi: 10.1155/2014/468397. Epub 2014 Aug 13.
- Results publication: PubMed 25110531Anagnostis P, Adamidou F, Slavakis A, Polyzos SA, Selalmatzidou D, Panagiotou A, Athyros VG, Karagiannis A, Kita M. Comparative Effect of Atorvastatin and Rosuvastatin on 25-hydroxy-Vitamin D Levels in Non-diabetic Patients with Dyslipidaemia: A Prospective Randomized Open-label Pilot Study. Open Cardiovasc Med J. 2014 Jul 11;8:55-60. doi: 10.2174/1874192401408010055. eCollection 2014.
- Results publicationDemir CC, Mousa U, Anil C. Effects of atorvastatin and rosuvastatin therapy on serum 25-hydroxyvitamin D levels: A comparative study 13th European Congress of Endocrinology. Endocr Abstr. 2011;26(1):548.
- Results publicationBauddh NK, Ranga GS. A study of the effect of rosuvastatin on vitamin D levels in patients with hypertension, diabetes mellitus, and coronary artery disease. Int J Health Sci Res. 2016; 6(7):42-6
- Results publication: PubMed 33283767Patwardhan VG, Mughal ZM, Padidela R, Chiplonkar SA, Khadilkar VV, Khadilkar AV. To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial. Indian J Pharmacol. 2020 Sep-Oct;52(5):365-371. doi: 10.4103/ijp.IJP_93_18.
- Results publicationJorge AJ, Cordeiro JR, Rosa ML, Bianchi DB. Vitamin D deficiency and cardiovascular diseases. Int J Cardiovas Sci. 2018;31(1):422-32
- Results publication: PubMed 27719645Sahebkar A, Reiner Z, Simental-Mendia LE, Ferretti G, Della Corte C, Nobili V. Impact of Statin Therapy on Plasma Vitamin D Levels: A Systematic Review and Meta-Analysis. Curr Pharm Des. 2017;23(6):861-869. doi: 10.2174/1381612822666161006150542.
- Results publicationRadhakrishnan A, Ruckmani A, Abishek M, Govindaraju S. Statin therapy and Vitamin D. Int J Basic Clin Pharmacol. 2015;4:1113-7.
- Results publication: PubMed 22323613Bhattacharyya S, Bhattacharyya K, Maitra A. Possible mechanisms of interaction between statins and vitamin D. QJM. 2012 May;105(5):487-91. doi: 10.1093/qjmed/hcs001. Epub 2012 Feb 9. No abstract available.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Uzma Malik study chair
King Edward Medical University
Ali Hussnain principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 20 mg/day and Atorvastatin 40 mg in people with Acute Coronary Syndromes, run by King Edward Medical University at 1 site in Pakistan.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. 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 Pakistan. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Hussnain (+923317641096, ahshah12@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin D (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765265, which also lists 14 linked publications.
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 11 Mar 2025.