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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00912756
Recruitment Status : Unknown
Verified July 2010 by Kansai Rosai Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2009
Last Update Posted : July 22, 2010
Association for Establishment of Ebvidence in Interventions
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Arteriosclerosis Obliterans Drug: cilostazol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
Study Start Date : March 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: 1cilostazol
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.
Drug: cilostazol
200 mg/day BID

Active Comparator: 2aspirin
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.
Drug: cilostazol
200 mg/day BID

Primary Outcome Measures :
  1. Angiographic restenosis rate [ Time Frame: 12 months +- 1 month ]

Secondary Outcome Measures :
  1. Cardiovascular events

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00912756

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Contact: Osamu Iida +81-6-6416-1221
Contact: Shinsuke Nanto +81-6-6416-1221

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Shinkoga Hospital Not yet recruiting
Kurume city, Fukuoka, Japan, 8308577
Contact: Shintani Yoshiaki    81-942-38-2222      
Hyogo College of Medicine Hopital Not yet recruiting
Nishinomiya city, Hyogo, Japan, 663-8501
Contact: Daizo Kawasaki    0798-45-6111      
Department of Cardiology, Kanazawa Cardiovascular Hospital Not yet recruiting
Kanazawa city, Ishikawa, Japan, 920-0007
Contact: Taketsugu Tsuchiya    81-76-253-8000      
Department of Cardiology,Naganoken Koseiren Shinonoi Recruiting
Nagano-city, Nagano, Japan, 3888004
Contact: Norihiko Shinozaki    81-26-292-2261      
Omihachiman Community Medical Center Not yet recruiting
Omihachiman city, Shiga, Japan, 523-0082
Contact: Kan Zen    81-748-33-3151      
Kansai Rosai Hospital and seven others Recruiting
Amagasaki, Japan
Principal Investigator: Osamu Iida         
Kishiwada Tokushukai Hospital Recruiting
Kishiwada, Japan
Contact: Yoshiaki Yokoi    81-72-445-9915      
Kokura Memorial Hospital Recruiting
Kitakyusy, Japan
Contact: Hiroyoshi Yokoi    81-93-921-2231      
Shinshu University Hospital Recruiting
Matsumoto, Japan
Contact: Yusuke Miyashita    81- 263-35-4600      
Caress Sapporo Tokeidai Memorial Hospital Recruiting
Sapporo, Japan
Contact: Kazushi Urasawa    81-11-251-1221      
Sendai Kousei Hospital Recruiting
Sendai, Japan
Contact: Naoto Inoue    81-22-222-6181      
Kikuna Memorial Hospital Recruiting
Yokohama, Japan
Contact: Akira Miyamoto    81-45-402-7111      
Saiseikai Yokohama- City Eastern Hospital Recruiting
Yokohama, Japan
Contact: Keisuke Hirano    81-45-576-3000      
Sponsors and Collaborators
Kansai Rosai Hospital
Association for Establishment of Ebvidence in Interventions
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Study Director: Osamu Iida Kansai Rosai Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Osamu Iida, Kansai Rosai Hospital Identifier: NCT00912756    
Other Study ID Numbers: STOP-IC
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010
Keywords provided by Kansai Rosai Hospital:
endovascular therapy
femoropopliteal artery lesions
Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area
Additional relevant MeSH terms:
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Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors