CUHK_CCT00319
2012-04-24
Prospective
N/A
CUHK Neurology Research Fund
N/A
N/A
Miss Pauline Kwan
Room 124010, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT, Hong Kong
2635 2160
paulinekwan@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
2015-08-11
ChiCTR-TRC-12002138
2012-05-01
|
|
|
|
---|---|---|---|
No documents yet. |