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Completed

NCT Number: NCT03248401

Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus

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Key information

Conditions

Type 2 Diabetes Mellitus Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Atherosclerosis Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 30 and 80 years
  • Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
  • Carotid plaque on 3D ultrasound

Exclusion criteria

  • Acute bleeding or bleeding tendency
  • Diagnosed with heart failure
  • Suggestive of ischemia on ECG
  • Uncontrolled hypertension
  • Recently diagnosed with peptic ulcer disease
  • Taking other antiplatelet agents
  • Hypersensitivity to salicylic acid
  • Aspirin induced asthma
  • Severe kidney, liver, heart disease

Treatment and study plan

Cilostazol

Drug

Cilostazol 200 mg/day

Aspirin

Drug

Aspirin 100 mg/day

Primary outcomes

  1. Change of carotid artery atherosclerosis

    Time frame: 6 months

    Plaque composition

Secondary outcomes

  1. Change of carotid artery atherosclerosis 1

    Time frame: 6 months

    Changes in carotid intima-media thickness after treatment

  2. Change of carotid artery atherosclerosis 2

    Time frame: 6 months

    Changes in carotid artery stenosis after treatment

  3. Change of carotid artery atherosclerosis 3

    Time frame: 6 months

    Plaque volume in carotid artery

Other outcomes

  1. Glucose metabolism 1

    Time frame: 6 months

    HOMA-Insulin Resistance

  2. Diabetic complication

    Time frame: 6 months

    Albuminuria

  3. Glucose metabolism 2

    Time frame: 6 months

    HbA1c

  4. Body composition

    Time frame: 6 months

    Body fat mass and percent

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 14, 2017
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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