Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00319

2 Trial Registration Date

2012-04-24

iRegistration 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

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

i Name

Miss Pauline Kwan

ii Address

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

iii Phone

2635 2160

iv Email

paulinekwan@gmail.com

v Affiliation

Department of Medicine & Therapeutics

vi Country

8Research 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

13Research 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

15Intervention

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

16Comparative 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

17Key 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

19Study 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

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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

Back History

Trial Detail