To evaluate the effect of concomitant administration of Probucol and Cilostazol (based on Atorvastatin treatment) on the atherosclerosis related markers (including the thickness of the Achilles tendon) in severe hypercholesterolemia subject, through the observation of the thickness of the Achilles tendon, the thickness of mean carotid intima-media, anti-oxidation biomarkers and serum lipid profile.
Multicenter, randomized, controlled, single-blinded, three parallel arms study. Group A: Atorvastatin + Probucol-placebo + Cilostazol-placebo Group B: Atorvastatin + Probucol + Cilostazol-placebo Group C: Atorvastatin + Probucol + Cilostazol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Anzhen hospital
Beijing, China
the effect of concomitant administration of Probucol and Cilostazol on the mean achilles tendon thickness (ATT)
Time frame: at Month 6, 12 and 24
the additional effect of concomitant administration of Probucol and Cilostazol on mean carotid intima-media thickness (IMT)
Time frame: at Month 12 and 24
the preventive effect of concomitant administration of Probucol and Cilostazol on the incidence of cerebrovascular and cardiovascular events (including intervention)
Time frame: 2 years
the effect of concomitant administration of Probucol and Cilostazol on biomarkers
Time frame: 2 years
the safety of Probucol or concomitant administration of Probucol and Cilostazol as determined by physical examination, vital signs, adverse events (AEs), laboratory examinations and 12-lead electrocardiogram (ECGs)
Time frame: 2 years
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