Melatonin on Coronary Artery Calcification

Phase 4

• Conditions: Coronary Artery Calcification
• Interventions: Drug: Melatonin 3 mg; Drug: Placebo

• Registration Number: NCT03966235
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

CAC is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Study Start: 2019-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

Exclusion Criteria

1. unstable angina pectoris
2. symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%
3. atrial fibrillation or other arrhythmias
4. type I diabetes mellitus or uncontrolled type II diabetes mellitus
5. renal failure
6. liver disease
7. gastrointestinal disease that affected absorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin group	Melatonin 3 mg	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.
Control group	Placebo	drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.

Primary Outcome Measures

Name	Time	Method
a change in CAC score at 6 months measured by coronary CTA	at 6 months	The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.

Secondary Outcome Measures

Name	Time	Method
malondialdehyde (MDA) level	at 6 months	a change in malondialdehyde (MDA) level at 6 months after treatment.
high-sensitivity C-reactive protein (hsCRP) level	at 6 months	a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.

Trial Locations

Locations (1)

PLA general hospital; 🇨🇳 Beijing, China