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

Primary Purpose

Arteriosclerosis Obliterans

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
cilostazol
Sponsored by
Kansai Rosai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arteriosclerosis Obliterans focused on measuring endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shinkoga Hospital
  • Hyogo College of Medicine Hopital
  • Department of Cardiology, Kanazawa Cardiovascular Hospital
  • Department of Cardiology,Naganoken Koseiren ShinonoiRecruiting
  • Omihachiman Community Medical Center
  • Kansai Rosai Hospital and seven othersRecruiting
  • Kishiwada Tokushukai HospitalRecruiting
  • Kokura Memorial HospitalRecruiting
  • Shinshu University HospitalRecruiting
  • Caress Sapporo Tokeidai Memorial HospitalRecruiting
  • Sendai Kousei HospitalRecruiting
  • Kikuna Memorial HospitalRecruiting
  • Saiseikai Yokohama- City Eastern HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1cilostazol

2aspirin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Angiographic restenosis rate

Secondary Outcome Measures

Cardiovascular events

Full Information

First Posted
June 2, 2009
Last Updated
July 21, 2010
Sponsor
Kansai Rosai Hospital
Collaborators
Association for Establishment of Ebvidence in Interventions
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1. Study Identification

Unique Protocol Identification Number
NCT00912756
Brief Title
Sufficient Treatment of Peripheral Intervention by Cilostazol
Acronym
STOP-IC
Official Title
Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kansai Rosai Hospital
Collaborators
Association for Establishment of Ebvidence in Interventions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis Obliterans
Keywords
endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1cilostazol
Arm Type
Experimental
Arm Description
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.
Arm Title
2aspirin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cilostazol
Intervention Description
200 mg/day BID
Primary Outcome Measure Information:
Title
Angiographic restenosis rate
Time Frame
12 months +- 1 month
Secondary Outcome Measure Information:
Title
Cardiovascular events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osamu Iida
Phone
+81-6-6416-1221
First Name & Middle Initial & Last Name or Official Title & Degree
Shinsuke Nanto
Phone
+81-6-6416-1221
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Iida
Organizational Affiliation
Kansai Rosai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shinkoga Hospital
City
Kurume city
State/Province
Fukuoka
ZIP/Postal Code
8308577
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shintani Yoshiaki
Phone
81-942-38-2222
Facility Name
Hyogo College of Medicine Hopital
City
Nishinomiya city
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daizo Kawasaki
Phone
0798-45-6111
Facility Name
Department of Cardiology, Kanazawa Cardiovascular Hospital
City
Kanazawa city
State/Province
Ishikawa
ZIP/Postal Code
920-0007
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taketsugu Tsuchiya
Phone
81-76-253-8000
Facility Name
Department of Cardiology,Naganoken Koseiren Shinonoi
City
Nagano-city
State/Province
Nagano
ZIP/Postal Code
3888004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norihiko Shinozaki
Phone
81-26-292-2261
Facility Name
Omihachiman Community Medical Center
City
Omihachiman city
State/Province
Shiga
ZIP/Postal Code
523-0082
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kan Zen
Phone
81-748-33-3151
Facility Name
Kansai Rosai Hospital and seven others
City
Amagasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamu Iida
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiaki Yokoi
Phone
81-72-445-9915
Facility Name
Kokura Memorial Hospital
City
Kitakyusy
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyoshi Yokoi
Phone
81-93-921-2231
Facility Name
Shinshu University Hospital
City
Matsumoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Miyashita
Phone
81- 263-35-4600
Facility Name
Caress Sapporo Tokeidai Memorial Hospital
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazushi Urasawa
Phone
81-11-251-1221
Facility Name
Sendai Kousei Hospital
City
Sendai
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoto Inoue
Phone
81-22-222-6181
Facility Name
Kikuna Memorial Hospital
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Miyamoto
Phone
81-45-402-7111
Facility Name
Saiseikai Yokohama- City Eastern Hospital
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keisuke Hirano
Phone
81-45-576-3000

12. IPD Sharing Statement

Citations:
PubMed Identifier
29706129
Citation
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.
Results Reference
derived
PubMed Identifier
23652861
Citation
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.
Results Reference
derived

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Sufficient Treatment of Peripheral Intervention by Cilostazol

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