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NAC Treatment and Outcomes in Patients With Advanced Atherosclerosis and DM

NCT05908513 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-06-18

No results posted yet for this study

Summary

Atherosclerosis and diabetes are related to coronary artery disease and peripheral artery disease. The mechanisms are related to increased reactive oxygen species (ROS) formation and inflammatory cytokine secretion. However, simply using antioxidant or anti-inflammatory therapies has no optimal outcomes. On the other hand, N-acetylcysteine (NAC) which has both antioxidant and anti-inflammatory effects could effectively attenuate ROS production and reduce vascular inflammation. Hence, we will investigate the effect of NAC treatment on the outcomes in patients with advanced atherosclerotic heart diseases and patients with diabetes combined with significant peripheral artery disease.

Conditions

Interventions

DRUG

N-acetylcysteine

Will be used as capsule form, 600mg per day if the patient can tolerate it. If not, we may decrease the dosage.

DRUG

Placebo

Similar chemical structure of NAC but without function

Sponsors & Collaborators

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Central South University

    collaborator OTHER

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2021-10-15
Completion
2021-10-15
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908513 on ClinicalTrials.gov