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Melatonin in Patients Under Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT03115034
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
The main purpose of this study is to evaluate the effects of melatonin in the regulation of the vascular injury in patients under carotid endarterectomy through population-based, randomized, double-blind, placebo-controlled trial.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Melatonin Drug: placebo Other: blank Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Protective Effect of Melatonin in Patients Under Carotid Endarterectomy
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: CEA with melatonin
Patients under CEA with melatonin taken during perioperative period.
Drug: Melatonin
Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.

Placebo Comparator: CEA with placebo
Patients under CEA with placebo taken during perioperative period.
Drug: placebo
Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.

Sham Comparator: CEA with blank control
Patients under CEA with nothing unnecessary taken during perioperative period.
Other: blank
Patients under CEA without taking melatonin or placebo




Primary Outcome Measures :
  1. Melatonin effects on patients under CEA assessed by the concentration of SOD [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of SOD by ELISA kit.

  2. Melatonin effects on patients under CEA assessed by the concentration of MDA [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of MDA by ELISA kit.

  3. Melatonin effects on patients under CEA assessed by the concentration of S100b [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of S100b by ELISA kit.

  4. Melatonin effects on patients under CEA assessed by the concentration of eNOS [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of eNOS by ELISA kit.

  5. Melatonin effects on patients under CEA assessed by the concentration of Nrf-2 [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of Nrf-2 by ELISA kit.

  6. Melatonin effects on patients under CEA assessed by the concentration of IL-6 [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of IL-6 by ELISA kit.

  7. Melatonin effects on patients under CEA assessed by the concentration of NF-κB p65 [ Time Frame: 3 months ]
    Melatonin effects on patients under CEA are detected by the concentration of NF-κB p65 by ELISA kit.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with carotid stenosis
  • had indications for carotid endarterectomy (CEA)

Exclusion Criteria:

  • surgical contraindication
  • cardiovascular disease
  • cerebral infarction within 3 months
  • psychiatric disorders
  • cancer
  • pregnant
  • lactating
  • taking antipsychotic drugs during perioperative period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115034


Locations
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China, Beijing
Changwei Liu
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Changwei Liu, MD Peking Union Medical College Hospital

Publications:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03115034     History of Changes
Other Study ID Numbers: LCW-ZS1057
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
carotid stenosis
melatonin
vascular injury
ischemia reperfusion

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants