CompletedPhase 4

Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study Subject

China200 participantsStarted 2009-03

Plain-language summary

Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .

Who can participate

Age range40 Years – 80 Years

SexALL

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Inclusion criteria

✓. 40～80-year-old male or female
✓. By brain CT or MRI result, cerebral infarction is clarified diagnosis within 1 year
✓. With atherosclerosis, atherosclerosis should meet at least one of the conditions as below:
✓. Has Aspirin regularly for more than 1 month before registration
✓. Informed Consent Form signature

Exclusion criteria

✕. Has an allergic history to study drugs( including of Probucol and Cilostazol) and Aspirin
✕. Had lipid-lowing agents within the last 3 months ( except Statins)
✕. Had antiplatelet or anticoagulation agents within the last 3 months (except Aspirin)
✕. Had acute cerebral infarction within the last 1 month
✕. Has cardiogenic cerebral embolism
✕. At the registration ,Modified Rankin Scale ≥ 4
✕. Hemorrhagic tendency or hemorrhagic disease (such as cerebral hemorrhage, gastrointestinal tract hemorrhage, etc.)
✕. Had a myocardial infarction, angina pectoris within the last 3 months

What they're measuring

After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.

Timeframe: 12 week

Trial details

NCT IDNCT00823875

SponsorOtsuka Beijing Research Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Atherosclerosis Cerebral Infarction trials