Arteriosclerosis ObliteransPhase 4STOP-ICNCT00912756
Sufficient Treatment of Peripheral Intervention by Cilostazol
A Phase 4 study testing cilostazol in people with Arteriosclerosis Obliterans, run by Kansai Rosai Hospital at 13 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arteriosclerosis Obliterans
- What is being tested?
- cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesJapan
- Study dates
- Mar 2009to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- Lesion criteria:
- Remnant inflow
- Severe calcification
- No arterial runoff below the knee
Trial locations and contacts
13 sites in 1 country.
Osamu Iida contact
Shinsuke Nanto contact
13 sites in 1 country
Japan13 sites, 13 recruiting
- Recruiting
Kansai Rosai Hospital and seven others
Amagasaki
Osamu Iida
- Not yet recruiting
Department of Cardiology, Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, 920-0007
Taketsugu Tsuchiya, 81-76-253-8000
- Recruiting
Kishiwada Tokushukai Hospital
Kishiwada
Yoshiaki Yokoi, 81-72-445-9915
- Recruiting
Kokura Memorial Hospital
Kitakyusy
Hiroyoshi Yokoi, 81-93-921-2231
- Not yet recruiting
Shinkoga Hospital
Kurume, Fukuoka, 8308577
Shintani Yoshiaki, 81-942-38-2222
- Recruiting
Shinshu University Hospital
Matsumoto
Yusuke Miyashita, 81- 263-35-4600
- Recruiting
Department of Cardiology,Naganoken Koseiren Shinonoi
Nagano, Nagano, 3888004
Norihiko Shinozaki, 81-26-292-2261
- Not yet recruiting
Hyogo College of Medicine Hopital
Nishinomiya, Hyōgo, 663-8501
Daizo Kawasaki, 0798-45-6111
- Not yet recruiting
Omihachiman Community Medical Center
Ōmihachiman, Shiga, 523-0082
Kan Zen, 81-748-33-3151
- Recruiting
Caress Sapporo Tokeidai Memorial Hospital
Sapporo
Kazushi Urasawa, 81-11-251-1221
- Recruiting
Sendai Kousei Hospital
Sendai
Naoto Inoue, 81-22-222-6181
- Recruiting
Kikuna Memorial Hospital
Yokohama
Akira Miyamoto, 81-45-402-7111
- Recruiting
Saiseikai Yokohama- City Eastern Hospital
Yokohama
Keisuke Hirano, 81-45-576-3000
About this study
Official title: 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.
- Conditions
- Arteriosclerosis Obliterans
- Being tested
- cilostazol
- Keywords
- endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area
- Medical subject headings
- Arteriosclerosis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilostazolDrug
200 mg/day BID
| Study group | Role | What they receive |
|---|---|---|
| 1cilostazol | Experimental | 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. Receives: Drug: cilostazol |
| 2aspirin | Active comparator | 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. Receives: Drug: cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic restenosis rate
Measured: 12 months +- 1 month
Secondary outcomes (1)
Cardiovascular events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arteriosclerosis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansai Rosai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Association for Establishment of Ebvidence in Interventions
- Investigators
- Osamu Iida, Study director, Kansai Rosai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912756
- Sponsor's protocol ID
- STOP-IC
- Acronym
- STOP-IC
- Status last verified
- Jul 2010
- First submitted
- 2 Jun 2009
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29706129Iida 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.
PubMed 23652861
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment
- ClinicalTrials.gov ID
- NCT00912756
- Acronym / sponsor ID
- STOP-IC / STOP-IC
- Conditions
- Arteriosclerosis Obliterans
- Keywords
- endovascular therapy, restenosis, cilostazol, femoropopliteal artery lesions, Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kansai Rosai HospitalUniversity, hospital or other
- Collaborators
- Association for Establishment of Ebvidence in Interventions
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1cilostazol | Experimental | Drug: cilostazolCilostazol 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. |
| 2aspirin | Active comparator | Drug: cilostazolNon-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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cilostazol200 mg/day BID | Drug | 1cilostazol, 2aspirin |
Primary outcome
Angiographic restenosis rate
Time frame: 12 months +- 1 month
1 secondary outcome
Cardiovascular events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Derived from this study: PubMed 29706129Soga 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.
- Derived from this study: PubMed 23652861Iida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osamu Iida contact
Shinsuke Nanto contact
Osamu Iida study director
Kansai Rosai Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cilostazol in people with Arteriosclerosis Obliterans, run by Kansai Rosai Hospital at 13 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osamu Iida (+81-6-6416-1221), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic restenosis rate (time frame: 12 months +- 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.