Suffcient Treatment Of Peripheral Intervention by Cilostazol

UMIN ID: UMIN000002091

Registered date:18/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Patient with Peripheral Artery Disease
• Date of first enrollment: 2009/03/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Angiographic restenosis rate (12 months)(-1month+1month)
• Secondary Outcome: 1.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 minimum: 20years-old
• Age maximum: 99years-old
• Gender: Male and Female
• Exclude criteria: Exclusion 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

• Primary Sponsor: Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hosp
• Source(s) of Monetary Support: Association for Establishment of Evidence in Interventions.
• Secondary ID(s): NCT00912756