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

July 21, 2010 updated by: Kansai Rosai Hospital

Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Amagasaki, Japan
        • Recruiting
        • Kansai Rosai Hospital and seven others
        • Principal Investigator:
          • Osamu Iida
      • Kishiwada, Japan
        • Recruiting
        • Kishiwada Tokushukai Hospital
        • Contact:
          • Yoshiaki Yokoi
          • Phone Number: 81-72-445-9915
      • Kitakyusy, Japan
        • Recruiting
        • Kokura Memorial Hospital
        • Contact:
          • Hiroyoshi Yokoi
          • Phone Number: 81-93-921-2231
      • Matsumoto, Japan
        • Recruiting
        • Shinshu University Hospital
        • Contact:
          • Yusuke Miyashita
          • Phone Number: 81- 263-35-4600
      • Sapporo, Japan
        • Recruiting
        • Caress Sapporo Tokeidai Memorial Hospital
        • Contact:
          • Kazushi Urasawa
          • Phone Number: 81-11-251-1221
      • Sendai, Japan
        • Recruiting
        • Sendai Kousei Hospital
        • Contact:
          • Naoto Inoue
          • Phone Number: 81-22-222-6181
      • Yokohama, Japan
        • Recruiting
        • Kikuna Memorial Hospital
        • Contact:
          • Akira Miyamoto
          • Phone Number: 81-45-402-7111
      • Yokohama, Japan
        • Recruiting
        • Saiseikai Yokohama- City Eastern Hospital
        • Contact:
          • Keisuke Hirano
          • Phone Number: 81-45-576-3000
    • Fukuoka
      • Kurume city, Fukuoka, Japan, 8308577
        • Not yet recruiting
        • Shinkoga Hospital
        • Contact:
          • Shintani Yoshiaki
          • Phone Number: 81-942-38-2222
    • Hyogo
      • Nishinomiya city, Hyogo, Japan, 663-8501
        • Not yet recruiting
        • Hyogo College of Medicine Hopital
        • Contact:
          • Daizo Kawasaki
          • Phone Number: 0798-45-6111
    • Ishikawa
      • Kanazawa city, Ishikawa, Japan, 920-0007
        • Not yet recruiting
        • Department of Cardiology, Kanazawa Cardiovascular Hospital
        • Contact:
          • Taketsugu Tsuchiya
          • Phone Number: 81-76-253-8000
    • Nagano
      • Nagano-city, Nagano, Japan, 3888004
        • Recruiting
        • Department of Cardiology,Naganoken Koseiren Shinonoi
        • Contact:
          • Norihiko Shinozaki
          • Phone Number: 81-26-292-2261
    • Shiga
      • Omihachiman city, Shiga, Japan, 523-0082
        • Not yet recruiting
        • Omihachiman Community Medical Center
        • Contact:
          • Kan Zen
          • Phone Number: 81-748-33-3151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Angiographic restenosis rate
Time Frame: 12 months +- 1 month
12 months +- 1 month

Secondary Outcome Measures

Outcome Measure
Cardiovascular events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansai Rosai Hospital

Collaborators

Association for Establishment of Ebvidence in Interventions

Investigators

  • Study Director: Osamu Iida, Kansai Rosai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

September 1, 2012

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (ESTIMATE)

June 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP-IC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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