Sufficient Treatment of Peripheral Intervention by Cilostazol

Arteriosclerosis Obliterans Clinical Trial

— STOP-IC  

Official title:

Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00912756
• Other study ID #: STOP-IC
• Status: Recruiting
• Phase: Phase 4
• First received: June 2, 2009
• Last updated: July 21, 2010
• Start date: March 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2010
• Source: Kansai Rosai Hospital
• Contact: Osamu Iida
• Phone: +81-6-6416-1221
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans

Intervention

Drug:
• cilostazol
200 mg/day BID

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital and seven others	Amagasaki
Japan	Department of Cardiology, Kanazawa Cardiovascular Hospital	Kanazawa city	Ishikawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada
Japan	Kokura Memorial Hospital	Kitakyusy
Japan	Shinkoga Hospital	Kurume city	Fukuoka
Japan	Shinshu University Hospital	Matsumoto
Japan	Department of Cardiology,Naganoken Koseiren Shinonoi	Nagano-city	Nagano
Japan	Hyogo College of Medicine Hopital	Nishinomiya city	Hyogo
Japan	Omihachiman Community Medical Center	Omihachiman city	Shiga
Japan	Caress Sapporo Tokeidai Memorial Hospital	Sapporo
Japan	Sendai Kousei Hospital	Sendai
Japan	Kikuna Memorial Hospital	Yokohama
Japan	Saiseikai Yokohama- City Eastern Hospital	Yokohama

Sponsors (2)

Lead Sponsor	Collaborator
Kansai Rosai Hospital	Association for Establishment of Ebvidence in Interventions

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic restenosis rate		12 months +- 1 month	No
Secondary	Cardiovascular events			Yes