Melatonin on Coronary Artery Calcification (MelonCAC)

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Calcification

Treatments: Drug: Placebo; Drug: Melatonin 3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03966235

MelonCAC

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups, including a placebo group

Melatonin group

Experimental group

Description:

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.

Treatment:

Drug: Melatonin 3 mg

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo