Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC)

Kansai Rosai Hospital

Status and phase: Unknown; Phase 4

Conditions: Arteriosclerosis Obliterans

Treatments: Drug: cilostazol

Study type: Interventional

Funder types: Other

Identifiers

NCT00912756

STOP-IC

Details and patient eligibility

About

Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in 127 patients with similar diseases, the patency rate was significantly higher in the cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly inhibited restenosis during the first 1-year period following endovascular therapy when restenosis is most frequently observed. In addition, there have been sporadic reports that cilostazol was effective in preventing post-stenting restenosis in the coronary artery area.

Based on these results, this multicenter study is going to be conducted to prospectively evaluate the usefulness of cilostazol in lower limb endovascular therapy.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient criteria:

• Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area*
• Patients who can be monitored for at least 2 years after surgery

Lesion criteria:

• Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented
• At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
• Occlusive lesions may be included.

Exclusion criteria:

• Patients with or at risk of hemorrhagic complications or patients with bleeding tendency
• Patients with congestive cardiac failure
• Patients with a drug-eluting stent
• Patients with acute lower limb ischemia
• Patients with creatinine of 2 mg/dL or more(without dialysis)
• 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.

Lesion criteria:

• Remnant inflow
• Severe calcification
• No arterial runoff below the knee

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1cilostazol

Experimental group

Description:

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.

Treatment:

Drug: cilostazol

2aspirin

Active Comparator group

Description:

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.

Treatment:

Drug: cilostazol