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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Kansai Rosai Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Association for Establishment of Ebvidence in Interventions
Information provided by:
Kansai Rosai Hospital
ClinicalTrials.gov Identifier:
NCT00912756
First received: June 2, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Arteriosclerosis Obliterans
Drug: cilostazol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment

Resource links provided by NLM:


Further study details as provided by Kansai Rosai Hospital:

Primary Outcome Measures:
  • Angiographic restenosis rate [ Time Frame: 12 months +- 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular events [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912756

Locations
Japan
Shinkoga Hospital
Kurume city, Fukuoka, Japan, 8308577
Hyogo College of Medicine Hopital
Nishinomiya city, Hyogo, Japan, 663-8501
Department of Cardiology, Kanazawa Cardiovascular Hospital
Kanazawa city, Ishikawa, Japan, 920-0007
Department of Cardiology,Naganoken Koseiren Shinonoi
Nagano-city, Nagano, Japan, 3888004
Omihachiman Community Medical Center
Omihachiman city, Shiga, Japan, 523-0082
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
Sponsors and Collaborators
Kansai Rosai Hospital
Association for Establishment of Ebvidence in Interventions
Investigators
Study Director: Osamu Iida Kansai Rosai Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Osamu Iida, Kansai Rosai Hospital
ClinicalTrials.gov Identifier: NCT00912756     History of Changes
Other Study ID Numbers: STOP-IC 
Study First Received: June 2, 2009
Last Updated: July 21, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Kansai Rosai Hospital:
endovascular therapy
restenosis
cilostazol
femoropopliteal artery lesions
Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area

Additional relevant MeSH terms:
Arteriosclerosis
Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors

ClinicalTrials.gov processed this record on December 07, 2016