NCT06765265

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

January 3, 2025

Last Update Submit

March 7, 2025

Conditions

Acute Coronary Syndromes

Keywords

atorvastatinrosuvastatinVitamin DTriglycerideLipid Profile

Outcome Measures

Primary Outcomes (1)

  • Serum Vitamin D

    24 weeks

Secondary Outcomes (1)

  • Lipid Profile

    4 weeks & 24 weeks

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvatstain 40mg OD

Drug: Atorvastatin 40 mg

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 20mg

Drug: Rosuvastatin 20 mg/day

Interventions

Rosuvastatin 20 mg/dayDRUG

Rosuvastatin 20 mg / Day for 24 weeks

Rosuvastatin
Atorvastatin 40 mgDRUG

Atorvastatin 40mg / Day for 24 weeks

Atorvastatin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Coronary Syndrome
  • OH-Vitamin D levels between 30-70ng/ml

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (14)

  • 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

    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.

    PMID: 31147695RESULT

  • 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.

    PMID: 20817794RESULT

  • 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.

    PMID: 25197610RESULT

  • 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.

    PMID: 25110531RESULT

  • 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.

    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

    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.

    PMID: 33283767RESULT

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

    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.

    PMID: 27719645RESULT

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

    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.

    PMID: 22323613RESULT

  • 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.

    PMID: 31809866RESULT

  • 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.

    PMID: 28068529RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Uzma Malik

    King Edward Medical University

    STUDY CHAIR

  • Ali Hussnain

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Hussnain

CONTACT

+923317641096ahshah12@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Endocrinology

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 9, 2025

Study Start

January 5, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
January 2025-January 2026

Locations

PA(1)