Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome

NCT ID: NCT06765265

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-05

Study Completion Date

2026-01-01

Brief Summary

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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

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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

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Acute Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Atorvatstain 40mg OD

Group Type ACTIVE_COMPARATOR

Atorvastatin 40 mg

Intervention Type DRUG

Atorvastatin 40mg / Day for 24 weeks

Rosuvastatin

Rosuvastatin 20mg

Group Type EXPERIMENTAL

Rosuvastatin 20 mg/day

Intervention Type DRUG

Rosuvastatin 20 mg / Day for 24 weeks

Interventions

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Rosuvastatin 20 mg/day

Rosuvastatin 20 mg / Day for 24 weeks

Intervention Type DRUG

Atorvastatin 40 mg

Atorvastatin 40mg / Day for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Acute Coronary Syndrome

25 OH-Vitamin D levels between 30-70ng/ml

Exclusion Criteria

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sidrah Lodhi

Assistant Professor of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uzma Malik

Role: STUDY_CHAIR

King Edward Medical University

Ali Hussnain

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

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King Edward Medical University

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Ali Hussnain

Role: CONTACT

+923317641096

Facility Contacts

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AP Endocrinology

Role: primary

+923004683473

References

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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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 31147695 (View on PubMed)

Sathyapalan 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.

Reference Type RESULT
PMID: 20817794 (View on PubMed)

Thabit 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.

Reference Type RESULT
PMID: 25197610 (View on PubMed)

Anagnostis 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.

Reference Type RESULT
PMID: 25110531 (View on PubMed)

Demir 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.

Reference Type RESULT

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 33283767 (View on PubMed)

Jorge AJ, Cordeiro JR, Rosa ML, Bianchi DB. Vitamin D deficiency and cardiovascular diseases. Int J Cardiovas Sci. 2018;31(1):422-32

Reference Type RESULT

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.

Reference Type RESULT
PMID: 27719645 (View on PubMed)

Radhakrishnan A, Ruckmani A, Abishek M, Govindaraju S. Statin therapy and Vitamin D. Int J Basic Clin Pharmacol. 2015;4:1113-7.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 22323613 (View on PubMed)

Scragg 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.

Reference Type RESULT
PMID: 31809866 (View on PubMed)

Verdoia 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.

Reference Type RESULT
PMID: 28068529 (View on PubMed)

Other Identifiers

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508/RC/KEMU/13-11-2023

Identifier Type: -

Identifier Source: org_study_id

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