NCT01291641

Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease

Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy: A Randomized, Multicenter, Multinational Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean IMT) at year 1, 2, and 3.

Detailed description

Hyperlipidemic patients who are currently receiving HMGCoA reductase inhibitors(Statins) will be randomized Group A(Control), Group B(Probucol only added group) or Group C(Probucol and cilostazol added group) . Randomization will be done by the minimization method, controlling for the following factors: Country(Korea vs China) and max IMT (≥2.0mm vs.\<2.0mm). Group A : HMGCoA reductase inhibitor continued Group B : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID Group C : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID +Cilostazol 100 mg PO, BID

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	HMG-CoA Reductase Inhibitor	During the study period, HMGCoA reductase inhibitor is continuously administered to the patients. Dosage regimen: following the package insert of each HMGCoA reductase inhibitor
DRUG	Probucol	In addition to the continued HMGCoA reductase inhibitor treatment, probucol is administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner)
DRUG	Cilostazol	In addition to the continued HMGCoA reductase inhibitor treatment, probucol and cilostazol are administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) Cilostazol 100-mg tablet, twice daily by the oral route

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2011-02-08
• Last updated: 2019-09-20

Locations

5 sites across 1 country: South Korea