Sufficient Treatment of Peripheral Intervention by Cilostazol
STOP-IC
Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
1 other identifier
interventional
200
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 22, 2010
July 1, 2010
3.3 years
June 2, 2009
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic restenosis rate
12 months +- 1 month
Secondary Outcomes (1)
Cardiovascular events
Study Arms (2)
1cilostazol
EXPERIMENTALCilostazol 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
ACTIVE COMPARATORNon-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.
Interventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Shinkoga Hospital
Kurume, Fukuoka, 8308577, Japan
Hyogo College of Medicine Hopital
Nishinomiya, Hyōgo, 663-8501, Japan
Department of Cardiology, Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, 920-0007, Japan
Department of Cardiology,Naganoken Koseiren Shinonoi
Nagano, Nagano, 3888004, Japan
Omihachiman Community Medical Center
Ōmihachiman, Shiga, 523-0082, 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
Related Publications (2)
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.
PMID: 29706129DERIVEDIida 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.
PMID: 23652861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Osamu Iida
Kansai Rosai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 3, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
July 22, 2010
Record last verified: 2010-07