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Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)

Fudan University logo

Fudan University

Status

Unknown

Conditions

Mild Cognitive Impairment

Treatments

Drug: Aspirin
Drug: Cilostazol

Study type

Interventional

Funder types

Other

Identifiers

NCT01872858
jianhuifu2013

Details and patient eligibility

About

Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.

Enrollment

200 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Aged between 50-80, both gender;
  2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND;
  3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.
  4. Normal hepatic and renal function.
  5. With good compliance.

Exclusion criteria

  1. Aged above 80 or less than 50.
  2. Dementia.
  3. Cerebral infarction(>2cm).
  4. Major vascular lesion. (stenosis>50%).
  5. Cardiac cerebral infarction.
  6. Intracerebral Hemorrhage.
  7. Clinical manifestations cannot attribute to small vessel disease.
  8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.
  9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).
  10. Thrombocytopenic Purpura.
  11. History of hemorrhage in digestive system or surgery in past 3 months.
  12. Previously on cilostazol treatment for more than 3 month.
  13. Allergic to aspirin or cilostazol.
  14. Enrolled in other clinical trials in past 3 months.
  15. Lack of informed consent or compliance.
  16. Contraindications for MRI scan.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Aspirin
Active Comparator group
Description:
Aspirin, 100mg, Q.D, p.o, 2yr
Treatment:
Drug: Aspirin
Cilostazol
Experimental group
Description:
cilostazol, 100mg, B.I.D, p.o, 2yr
Treatment:
Drug: Cilostazol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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