NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002091

Registered date:18/06/2009

Suffcient Treatment Of Peripheral Intervention by Cilostazol

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedPatient with Peripheral Artery Disease
Date of first enrollment2009/03/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1.Cilostazol group: Treatment with cilostazol 200 mg/day BID (morning and evening) and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period. 2.Non-cilostazol group: Treatment with aspirin 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period. In both groups, oral treatment with ticlopidine hydrochloride 200 mg/day BID (morning and evening) will be started 3 to 7 days prior to EVT and continued until 4 weeks after EVT (only stenting). If dose reduction of cilostazol is required due to adverse drug reactions such as headache, the dosage may be reduced to 100 mg/day BID.

Outcome(s)

Primary OutcomeAngiographic restenosis rate (12 months)(-1month+1month)
Secondary Outcome1.Patency rate 2.Ankle brachial pressure index (ABPI) 3.Absolute claudication distance (ACD) 4.Cardiovascular events (death, MI, stroke) 5.Lower limb vascular events (major or minor amputation, progression to bypass surgery, repeated revascularization, stent thrombosis) 6.Assessment of stent damage rate 7.Angiographic restenosis rate (24 months1 month) 8.Angiographic late loss (12 months1 month, 24 months1 month)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum99years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion criteria Patient criteria Patients who meet any of the following criteria should be excluded from the study: 1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency *Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated. 2.Patients with congestive cardiac failure (NYHA III or IV or EF<30%) 3.Patients with a drug-eluting stent (DES) 4.Patients with creatinine of 2 mg/dL or patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug. 5.Pregnant or potentially pregnant women 6.Patients with acute lower limb ischemia 7.Patients who are not eligible for the study in the opinion of the attending physician. Lesion criteria Lesions that meet any of the following criteria should be excluded from the study: 1.Remnant inflow (aorta-iliac artery lesion) 2.Severe calcification (lesions not expected to be appropriately expanded) 3.No arterial runoff below the knee

Related Information

Contact

public contact
Name Osamu Iida
Address 3-1-69 Inabaso, Amagasaki-shi, Hyogo 660-8511, Japan Japan
Telephone 06-6416-1221
E-mail
Affiliation Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hosp Internal medicine department
scientific contact
Name Osamu Iida
Address 3-1-69 Inabaso, Amagasaki-shi, Hyogo 660-8511, Japan Japan
Telephone 06-6416-1221
E-mail
Affiliation Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hospital Internal medicine department