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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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002138
Enrollment
Unknown
Registered
2012-05-01
Start date
2012-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Two groups:Simvastatin : 40mg daily Atorvastatin : 40mg daily / 60 mg daily / 80 mg daily vs Simvastatin 10 mg for two years

Sponsors

None listed

Eligibility

Sex/Gender
Male
Age
40 Years to 90 Years

Inclusion criteria

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.

Exclusion criteria

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*181mol/L or allergy to statins.

Design outcomes

Primary

MeasureTime frame
Change of MRI White Matter lesion Volume Time of measurement: Baseline, 1 year and 2 year MRI;

Secondary

MeasureTime frame
(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;

Countries

China

Contacts

Public ContactProfessor Vincent Mok
vctmok@cuhk.edu.hk+852 2632 2195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026