Sufficient Treatment of Peripheral Intervention by Cilostazol

Phase 4

• Conditions: Arteriosclerosis Obliterans
• Interventions: Drug: cilostazol

• Registration Number: NCT00912756
• Lead Sponsor: Kansai Rosai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-22
• Primary Completion: 2012-06
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1cilostazol	cilostazol	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.
2aspirin	cilostazol	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.

Primary Outcome Measures

Name	Time	Method
Angiographic restenosis rate	12 months +- 1 month

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events

Trial Locations

Locations (13)

Omihachiman Community Medical Center; 🇯🇵 Omihachiman city, Shiga, Japan

Department of Cardiology,Naganoken Koseiren Shinonoi; 🇯🇵 Nagano-city, Nagano, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyusy, Japan

Kishiwada Tokushukai Hospital; 🇯🇵 Kishiwada, Japan

Sendai Kousei Hospital; 🇯🇵 Sendai, Japan

Kikuna Memorial Hospital; 🇯🇵 Yokohama, Japan

Caress Sapporo Tokeidai Memorial Hospital; 🇯🇵 Sapporo, Japan

Shinkoga Hospital; 🇯🇵 Kurume city, Fukuoka, Japan

Department of Cardiology, Kanazawa Cardiovascular Hospital; 🇯🇵 Kanazawa city, Ishikawa, Japan

Kansai Rosai Hospital and seven others; 🇯🇵 Amagasaki, Japan

Shinshu University Hospital; 🇯🇵 Matsumoto, Japan

Hyogo College of Medicine Hopital; 🇯🇵 Nishinomiya city, Hyogo, Japan

Saiseikai Yokohama- City Eastern Hospital; 🇯🇵 Yokohama, Japan