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Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease (Challenge)

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: NCT01932203
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Inha University Hospital

Brief Summary:
There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.

Condition or disease Intervention/treatment Phase
Cerebral Small Vessel Disease Drug: aspirin Drug: cilostazol Phase 4

Detailed Description:

The primary objective of this study is to compare the efficacy of aspirin and cilostazol on volume of white matter changes in cerebral small vessel disease.

The secondary objectives are to compare the impact of aspirin and cilostazol on DTI parameters, lacune, microbleeds, brain atrophy, cognition, depression, neurologic signs, gait, urination, and activities of daily living.

We also investigate risk factors associated with progression of cerebral small vessel disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease
Actual Study Start Date : July 17, 2013
Actual Primary Completion Date : August 6, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: aspirin
aspirin 100mg by mouth once a day for 104 weeks
Drug: aspirin
100mg once a day

Experimental: Cilostazol
Pletaal SR 200mg by mouth once a day for 104 weeks
Drug: cilostazol
200mg once a day
Other Name: Pletaal SR




Primary Outcome Measures :
  1. Volume of white matter changes (WMCs) [ Time Frame: baseline, week 104 ]
    Measure change of WMC on brain MRI


Secondary Outcome Measures :
  1. Mean diffusivity (MD) and Fraction Anisotropy (FA) on Diffusion Tensor Imaging [ Time Frame: baseline and week 104 ]
    High MD and low FA means tissue damage.

  2. Number of lacunes [ Time Frame: baseline and week 104 ]
    High number means tissue damage.

  3. number of microbleeds [ Time Frame: baseline and week 104 ]
    High number means tissue damage.

  4. brain volume and cortical thickness [ Time Frame: baseline and week 104 ]
    Low score means tissue damage.

  5. Mini-Mental State Examination [ Time Frame: baseline, week 52, and week 104 ]
    Measure global cognition. Score range is 0-30. Higher score means good cognition.

  6. Neurocognitive test [ Time Frame: baseline, week 52, and week 104 ]
    Seoul Verbal Learning Test, Boston Naming test-short form, ROCF copy, animal fluency, phonemic fluency, Stroop test, Digit-symbol test, Trail making test

  7. Clinical Dementia Rating scale-sum of boxes [ Time Frame: baseline, week 52, and week 104 ]
    Measure global cognition. Score range is 0-18. Higher score means good cognition.

  8. King's Health Questionnaire [ Time Frame: baseline, week 42, and week 104 ]
    Measure voiding function. Higher score means bad function.

  9. Geriatric Depression Scale-Short form [ Time Frame: baseline, week 52, and week 104 ]
    Measure depression. Score range is 0-15. Higher score means depression.

  10. Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) [ Time Frame: baseline, week 52, and week 104 ]
    Measure abnormal behavior. Score range is 0-144. Higher score means severe abnormal behavior.

  11. Bayer Activities of Daily Living [ Time Frame: baseline, week 52, and week 104 ]
    Measure instrumental activities of daily living (ADL). Score range is 1-10. Higher score means bad ADL.

  12. Barthel Index [ Time Frame: baseline, week 52, and week 104 ]
    Measure physical ADL. Score range is 0-20. Higher score means good physical ADL.

  13. Pyramidal and Extrapyramidal Scale (PEPS) [ Time Frame: baseline, week 52, and week 104 ]
    Measure neurologic signs. Score range is 0-60. Higher score means many abnormal neurologic signs.

  14. Timed UP and Go (TUG) test [ Time Frame: basline, week 52, and week 104 ]
    Measure gait. Higher score means bad gait.

  15. Adverse event [ Time Frame: baseline, week 4, 16, 28, 40, 52, 64, 76, 88, and 104 ]
    measure any adverse events


Other Outcome Measures:
  1. All ischemic stroke event [ Time Frame: week 104 ]
    cerebral infarction and transient ischemic attack

  2. All vascular events [ Time Frame: week 104 ]
    including ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, cerebral venous thrombosis, pulmonary embolism, symptomatic deep vein thrombosis, symptomatic peripheral artery occlusion, other vascular occlusion, and any revascularization procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 to 85 years of age
  • He/She can walk to the hospital (walker or cane is permissible).
  • Cerebral small vessel disease is observed on brain MRI.

    1) presence of one or more lacunar infarction and 2) moderate or severe confluent leukoaraiosis (defined as grade 2 or 3 on a modified Fazekas scale): periventricular WMCs with cap or rims lager than 5mm and deep subcortical WMCs >10 mm in maximum diameter

  • written informed consent

Exclusion Criteria:

  • Any patient with contraindication of antiplatelets
  • Any patient with cardioembolic source
  • Carotid bruit or large cerebral artery stenosis >50%
  • Cortical infarction or subcortical infarction lager than 1.5 cm
  • bleeding tendency
  • chronic liver disease (AST or ALT >100 IL/L)
  • chronic renal disease (Creatinine >3.0mg/dL)
  • active gastrointestinal ulcer
  • any patients with any severe or unstable medical disease that may prevent them from completing study requirements (i.e., unstable or severe asthma)
  • Anemia (Hb <10g/dL) or thrombocytopenia
  • Cardiac pacemaker or contraindication to MRI
  • Pregnancy or breast-feeding
  • drug or alcohol addiction
  • Any other white matte disease (i.e., Multiple sclerosis, sarcoidosis, or brain irradiation, etc) or brain tumor
  • Parkinson's disease, Alzheimer's disease or any other neurodegenerative disease
  • any hearing or visual impairment that can disturb the efficient evaluation of the patient
  • recent cerebral infarction with 3 months

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): NCT01932203


Locations
Show Show 19 study locations
Sponsors and Collaborators
Inha University Hospital
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
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Principal Investigator: Seong Hye Choi, MD, PhD Inha University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inha University Hospital, Professor
ClinicalTrials.gov Identifier: NCT01932203    
Other Study ID Numbers: 20130006
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Inha University Hospital:
Cerebral small vessel disease
Leukoaraiosis
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Additional relevant MeSH terms:
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Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Cilostazol
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents