Sufficient Treatment of Peripheral Intervention by Cilostazol
NCT ID: NCT00912756
Last Updated: 2010-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2009-03-31
2012-09-30
Brief Summary
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Based on these results, this multicenter study is going to be conducted to prospectively evaluate the usefulness of cilostazol in lower limb endovascular therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
cilostazol
200 mg/day BID
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.
cilostazol
200 mg/day BID
Interventions
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cilostazol
200 mg/day BID
Eligibility Criteria
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Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Association for Establishment of Ebvidence in Interventions
UNKNOWN
Kansai Rosai Hospital
OTHER
Responsible Party
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Kansai Rosai Hospital
Principal Investigators
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Osamu Iida
Role: STUDY_DIRECTOR
Kansai Rosai Hospital
Locations
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Shinkoga Hospital
Kurume, Fukuoka, Japan
Hyogo College of Medicine Hopital
Nishinomiya, Hyōgo, Japan
Department of Cardiology, Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Department of Cardiology,Naganoken Koseiren Shinonoi
Nagano, Nagano, Japan
Omihachiman Community Medical Center
Ōmihachiman, Shiga, Japan
Kansai Rosai Hospital and seven others
Amagasaki, , Japan
Kishiwada Tokushukai Hospital
Kishiwada, , Japan
Kokura Memorial Hospital
Kitakyusy, , Japan
Shinshu University Hospital
Matsumoto, , Japan
Caress Sapporo Tokeidai Memorial Hospital
Sapporo, , Japan
Sendai Kousei Hospital
Sendai, , Japan
Kikuna Memorial Hospital
Yokohama, , Japan
Saiseikai Yokohama- City Eastern Hospital
Yokohama, , Japan
Countries
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Central Contacts
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Osamu Iida
Role: CONTACT
Shinsuke Nanto
Role: CONTACT
Facility Contacts
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Shintani Yoshiaki
Role: primary
Daizo Kawasaki
Role: primary
Taketsugu Tsuchiya
Role: primary
Norihiko Shinozaki
Role: primary
Kan Zen
Role: primary
Yoshiaki Yokoi
Role: primary
Hiroyoshi Yokoi
Role: primary
Yusuke Miyashita
Role: primary
Kazushi Urasawa
Role: primary
Naoto Inoue
Role: primary
Akira Miyamoto
Role: primary
Keisuke Hirano
Role: primary
References
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Soga Y, Hamasaki T, Edahiro R, Iida O, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Aodo K; STOP-IC investigators. Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study. J Endovasc Ther. 2018 Jun;25(3):306-312. doi: 10.1177/1526602818771358. Epub 2018 Apr 30.
Iida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Shintani Y, Miyamoto A, Hirano K, Miyashita Y, Tsuchiya T, Shinozaki N, Nakamura M, Isshiki T, Hamasaki T, Nanto S; STOP-IC investigators. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study. Circulation. 2013 Jun 11;127(23):2307-15. doi: 10.1161/CIRCULATIONAHA.112.000711. Epub 2013 May 7.
Other Identifiers
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STOP-IC
Identifier Type: -
Identifier Source: org_study_id
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