Sufficient Treatment of Peripheral Intervention by Cilostazol

NCT ID: NCT00912756

Last Updated: 2010-07-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Arteriosclerosis Obliterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

cilostazol

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

cilostazol

Intervention Type DRUG

200 mg/day BID

Interventions

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cilostazol

200 mg/day BID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association for Establishment of Ebvidence in Interventions

UNKNOWN

Sponsor Role collaborator

Kansai Rosai Hospital

OTHER

Sponsor Role lead

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

Site Status NOT_YET_RECRUITING

Hyogo College of Medicine Hopital

Nishinomiya, Hyōgo, Japan

Site Status NOT_YET_RECRUITING

Department of Cardiology, Kanazawa Cardiovascular Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status NOT_YET_RECRUITING

Department of Cardiology,Naganoken Koseiren Shinonoi

Nagano, Nagano, Japan

Site Status RECRUITING

Omihachiman Community Medical Center

Ōmihachiman, Shiga, Japan

Site Status NOT_YET_RECRUITING

Kansai Rosai Hospital and seven others

Amagasaki, , Japan

Site Status RECRUITING

Kishiwada Tokushukai Hospital

Kishiwada, , Japan

Site Status RECRUITING

Kokura Memorial Hospital

Kitakyusy, , Japan

Site Status RECRUITING

Shinshu University Hospital

Matsumoto, , Japan

Site Status RECRUITING

Caress Sapporo Tokeidai Memorial Hospital

Sapporo, , Japan

Site Status RECRUITING

Sendai Kousei Hospital

Sendai, , Japan

Site Status RECRUITING

Kikuna Memorial Hospital

Yokohama, , Japan

Site Status RECRUITING

Saiseikai Yokohama- City Eastern Hospital

Yokohama, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Osamu Iida

Role: CONTACT

+81-6-6416-1221

Shinsuke Nanto

Role: CONTACT

+81-6-6416-1221

Facility Contacts

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Shintani Yoshiaki

Role: primary

81-942-38-2222

Daizo Kawasaki

Role: primary

0798-45-6111

Taketsugu Tsuchiya

Role: primary

81-76-253-8000

Norihiko Shinozaki

Role: primary

81-26-292-2261

Kan Zen

Role: primary

81-748-33-3151

Yoshiaki Yokoi

Role: primary

81-72-445-9915

Hiroyoshi Yokoi

Role: primary

81-93-921-2231

Yusuke Miyashita

Role: primary

81- 263-35-4600

Kazushi Urasawa

Role: primary

81-11-251-1221

Naoto Inoue

Role: primary

81-22-222-6181

Akira Miyamoto

Role: primary

81-45-402-7111

Keisuke Hirano

Role: primary

81-45-576-3000

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.

Reference Type DERIVED
PMID: 29706129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23652861 (View on PubMed)

Other Identifiers

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STOP-IC

Identifier Type: -

Identifier Source: org_study_id

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