Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00430

2 Trial Registration Date

2014-08-04

iRegistration Status

Prospective

3 Secondary IDs

CRE-2013.680-T

4 Source(s) of Funding

General Research Fund

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Pauline Wing Lam Kwan

ii Address

Rm 124010, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T. Hong Kong

iii Phone

+852 26352160

iv Email

paulinekwan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8Research Contact Person (person to contact for scientific inquiries)

i Name

Vincent Chung Tong Mok

ii Address

Rm 124010, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T. Hong Kong

iii Phone

+852 2632 2195

iv Email

vctmok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Cilostazol in Decreasing progression of cerebral white matter hyperintensities (DREAM)

10 Public Title

Cilostazol in Decreasing progression of cerebral white matter hyperintensities (DREAM)

i Public Title in Chinese 研究名稱

抗凝血小板藥物『西洛他唑』用於抑制腦白質體病變之研究

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

White Matter Hyperintensities

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Cilostazol/Placebo

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

104 weeks

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

This will be a randomized, double-blind, placebo-controlled study. One hundred and forty dementia/stroke-free subjects having confluent WMH as defined by the global score of the Age-Related White Matter Changes scale of ≥2 will be randomized into active (cilostazol 100mg bd) (n=70) and placebo (n=70) treatment respectively, for 2 years. Primary outcome will be change of WMH volume on MRI, which will be quantified automatically. Secondary outcomes include change in other brain measures (lacunes, microbleeds, cortical grey matter and whole brain volumes, diffusion tensor imaging measures, arterial spin labeling) and clinical measures (Montreal Cognitive Assessment, executive and memory tests, behavior, instrumental activities of daily living, gait, incident clinical events [e.g. stroke, dementia]). Data on clinical and biochemistry measures will be collected at baseline, 1 year and 2 year; while MRI will be performed at baseline and 2 year. Safety will be assessed using adverse events and laboratory tests.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) Age 65-85; 2) Chinese ethnicity; 3) Presence of confluent on MRI*; and 4) Written informed consent given

ii Exclusion Criteria

1) History of stroke or TIA; 2) Dementia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition; 3.) Presence of peripheral arterial disease that necessitates use of cilostazol; 4) Concurrent use of antiplatelet agents or anticoagulants, e.g. aspirin, clopidogrel, warfarin; 5) Contraindications for use of cilostazol, e.g. heart failure, prior history of allergy to cilostazol; 6) Severe medical illnesses (e.g. malignancy, end-stage renal diseases); 7) Contraindication for MRI (e.g. claustrophobia, metallic implants)

iii Age Minimum

65

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-10-27

21 Target Sample Size

140

22 Recruitment Status

Recruiting

23 Primary Outcome

Change of WMH volume on MRI between baseline and end of study, which will be quantified with automatic computational method

24 Secondary Outcome

change in other brain measures in MRI (lacunes, microbleeds, brain volumes (cortical grey matter[cGM], white matter[WM], ventricular and sulcal CSF) and DTI measures (mean fractional anisotropy [FA] of WMH, normal appearing WM, GM)
Clinical measures (Montreal Cognitive Assessment, 30-minute battery of the NINDS- CSN VCI Neuropsychology Protocols, NPI, instrumental activities of daily living, gait and balance , incident clinical events [e.g. stroke, dementia])

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2015-08-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TCS-14005054

28 Date of Registration in Primary Registry

2014-08-05

Back History

Trial Detail