Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00319

2 Trial Registration Date

2012-04-24

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

CUHK Neurology Research Fund

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Miss Joan Khoo

ii Address

Room 124010, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT, Hong Kong

iii Phone

2632 3856

iv Email

crjoankhoo@gmail.com

v Affiliation

Department of Medicine & Therapeutics

vi Country

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

i Name

Professor Vincent Mok

ii Address

Room 114028, 9/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT, Hong Kong

iii Phone

2632 2195

iv Email

vctmok@cuhk.edu.hk

v Affiliation

Department of Medicine & Therapeutics

vi Country

9 Official Scientific Title of the Study

Statins and White Matter Lesion Progression: A Randomised, Open-Label, Parellel Group Study

10 Public Title

Statins and White Matter Lesion Progression: A Randomised, Open-Label, Parellel Group Study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-03-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

The effects of statins upon White Matter Lesion progression in dementia free stroke survivors who have confluent White matter leision

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Simvastatin : 40mg daily
Atorvastatin : 40mg daily / 60 mg daily / 80 mg daily

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Simvastatin 10 mg

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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1)Ischemic stroke patients aged 40-90
(2) MRI brain showing early confluent to confluent White Matter Lesion (Fazekas grading of 2 to 3)
(3) LDL cholesterol level of >=3 mmol/L
(4) Sufficient Chinese competency for cognitive testing
(5) Informed written consent given

ii Exclusion Criteria

(1)Stroke within 3 months of screening visit
(2)History of hemorrhagic stroke
(3)Dementia as defined by diagnostic and statistical manual, 4th edition (DSM-IV)
(4)History of ischemic heart disease
(5)Severe stroke (Modified Rankin scale (mRS) of > = 5 or aphasia that hinders cognitive assessment
(6)Significant medical co-morbidities associated with limited life expectancy
(7)Change of lipid-altering drugs within 3 months of screening visit
(8)Other contraindications to statins e.g. Alanine transferase (ALT of > 20% of upper limit of normal,
(9)elevated creatinine phosphokinae(CPK) level>180 µmol/L or allergy to statins

iii Age Minimum

40

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

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

2012-06-01

21 Target Sample Size

100

22 Recruitment Status

Unknown

23 Primary Outcome

Change of MRI White Matter lesion Volume

Time of measurement: Baseline, 1 year and 2 year MRI

24 Secondary Outcome

(1)Change in other brain measures
- lacunar infarcts
- Microbleeds
- brain volume
- diffusion tensor imaging
- breath holding index
- pulsatility index

(2)Change in clinical measures
- MoCA
- Executive and memory tests
- Instrumental activities of daily living [IADL]
- Behavior
- Gait
Time of Measurement - Baseline, 1 year and 2 year visits

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-11

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002138

28 Date of Registration in Primary Registry

2012-05-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-05-28