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Trial History Detail on 2014-05-28

CUHK_CCT00319

2012-04-24

Prospective

N/A

CUHK Neurology Research Fund

N/A

N/A

Miss Joan Khoo

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

2632 3856

crjoankhoo@gmail.com

Department of Medicine & Therapeutics

Professor Vincent Mok

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

2632 2195

vctmok@cuhk.edu.hk

Department of Medicine & Therapeutics

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

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

N/A

Hong Kong

Yes

2012-03-06

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

Drug

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

2 years

Simvastatin 10 mg

(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

(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

40

90

Both Male and Female

Interventional

Randomized

Dose comparison

Open label

Parallel

2012-06-01

100

Unknown

Change of MRI White Matter lesion Volume

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

(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

No

2015-08-11

ChiCTR-TRC-12002138

2012-05-01


Yes

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