NCT03966235

Brief Summary

We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

May 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 26, 2019

Last Update Submit

May 28, 2019

Conditions

Coronary Artery Calcification

Keywords

melatonincoronary artery calcificationadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • a change in CAC score at 6 months measured by coronary CTA

    The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.

    at 6 months

Secondary Outcomes (2)

  • high-sensitivity C-reactive protein (hsCRP) level

    at 6 months

  • malondialdehyde (MDA) level

    at 6 months

Study Arms (2)

Melatonin group

EXPERIMENTAL

drug: melatonin tablets (Sigma-Aldrich Co. LLC, St. Louis, MO, USA); the frequency:3mg melatonin tablet was taken daily; duration: study treatment was maintained for 6 months.

Drug: Melatonin 3 mg

Control group

PLACEBO COMPARATOR

drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.

Drug: Placebo

Interventions

Melatonin 3 mgDRUG

Melatonin was taken daily for 6 months.

Also known as: melatonin
Melatonin group
PlaceboDRUG

Placebo tablet was taken daily for 6 months.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (\<50% diameter lumen narrowing) were eligible for the study.

You may not qualify if:

  • unstable angina pectoris
  • symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) \<40%
  • atrial fibrillation or other arrhythmias
  • type I diabetes mellitus or uncontrolled type II diabetes mellitus
  • renal failure
  • liver disease
  • gastrointestinal disease that affected absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA general hospital

Beijing, 100853, China

RECRUITING

Related Publications (5)

  • Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14.

    PMID: 30476723BACKGROUND

  • Shobeiri N, Bendeck MP. Interleukin-1beta Is a Key Biomarker and Mediator of Inflammatory Vascular Calcification. Arterioscler Thromb Vasc Biol. 2017 Feb;37(2):179-180. doi: 10.1161/ATVBAHA.116.308724. No abstract available.

    PMID: 28122774BACKGROUND

  • Fernandez A, Ordonez R, Reiter RJ, Gonzalez-Gallego J, Mauriz JL. Melatonin and endoplasmic reticulum stress: relation to autophagy and apoptosis. J Pineal Res. 2015 Oct;59(3):292-307. doi: 10.1111/jpi.12264. Epub 2015 Aug 9.

    PMID: 26201382BACKGROUND

  • Dehdashtian E, Mehrzadi S, Yousefi B, Hosseinzadeh A, Reiter RJ, Safa M, Ghaznavi H, Naseripour M. Diabetic retinopathy pathogenesis and the ameliorating effects of melatonin; involvement of autophagy, inflammation and oxidative stress. Life Sci. 2018 Jan 15;193:20-33. doi: 10.1016/j.lfs.2017.12.001. Epub 2017 Dec 5.

    PMID: 29203148BACKGROUND

  • Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13.

    PMID: 26681403RESULT

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • yu jie zhou

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wei ren chen, MD

CONTACT

+8601066876231chen_weiren@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 26, 2019

First Posted

May 29, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)