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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03248401
Recruitment Status : Active, not recruiting
First Posted : August 14, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Carotid Atherosclerosis Drug: Cilostazol Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : October 21, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Cilostazol group
Cilostazol 200 mg or maximal tolerate dose
Drug: Cilostazol
Cilostazol 200 mg/day

Active Comparator: Aspirin group
Aspirin 100 mg
Drug: Aspirin
Aspirin 100 mg/day




Primary Outcome Measures :
  1. Change of carotid artery atherosclerosis [ Time Frame: 6 months ]
    Plaque composition


Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03248401


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital

Publications:
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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03248401     History of Changes
Other Study ID Numbers: Cilostazol_Carotid a. plaque
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Atherosclerosis
Carotid Artery Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Cilostazol
Phosphodiesterase 3 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors