Sufficient Treatment of Peripheral Intervention by Cilostazol - Full Text View

Sponsor:	Kansai Rosai Hospital
Collaborator:	Association for Establishment of Ebvidence in Interventions
Information provided by:	Kansai Rosai Hospital
ClinicalTrials.gov Identifier:	NCT00912756

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 IV

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:

Drug Information available for: Cilostazol

U.S. FDA Resources

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
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

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

Contacts

Contact: Osamu Iida	+81-6-6416-1221
Contact: Shinsuke Nanto	+81-6-6416-1221

Locations

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

Sponsors and Collaborators

Kansai Rosai Hospital

Association for Establishment of Ebvidence in Interventions

Investigators

Study Director:

Osamu Iida

Kansai Rosai Hospital

More Information

No publications provided

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
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012