Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Kansai Rosai Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kansai Rosai Hospital
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
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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 |
| 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 May 23, 2013