UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002091 |
|---|---|
| Receipt number | R000002524 |
| Scientific Title | Suffcient Treatment Of Peripheral Intervention by Cilostazol |
| Date of disclosure of the study information | 2009/06/18 |
| Last modified on | 2009/06/18 18:54:53 |
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Basic information
Public title
Suffcient Treatment Of Peripheral Intervention by Cilostazol
Acronym
STOP-IC
Scientific Title
Suffcient Treatment Of Peripheral Intervention by Cilostazol
Scientific Title:Acronym
STOP-IC
Region
| Japan |
Condition
Condition
Patient with Peripheral Artery Disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether cilostazol is effective in preventing restenosis following endovascular therapy (EVT) for femoropopliteal artery lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angiographic restenosis rate (12 months)(-1month+1month)
Key secondary outcomes
1.Patency rate
2.Ankle brachial pressure index (ABPI)
3.Absolute claudication distance (ACD)
4.Cardiovascular events (death, MI, stroke)
5.Lower limb vascular events
(major or minor amputation, progression to bypass surgery, repeated revascularization, stent thrombosis)
6.Assessment of stent damage rate
7.Angiographic restenosis rate (24 months1 month)
8.Angiographic late loss (12 months1 month, 24 months1 month)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.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.
Interventions/Control_2
2.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.
In both groups, oral treatment with ticlopidine hydrochloride 200 mg/day BID (morning and evening) will be started 3 to 7 days prior to EVT and continued until 4 weeks after EVT (only stenting).
If dose reduction of cilostazol is required due to adverse drug reactions such as headache, the dosage may be reduced to 100 mg/day BID.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
Patient criteria
Patients who meet all of the following criteria will be included in the study:
1. Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area*
(Rutherford classification 2-4) (see Appendix 1)
*Except for patients with acute (within 1 week after onset)/subacute (2 weeks to 1 month after onset) lower limb ischemia
2. Age: 20 years or older at the time of consent
3. Gender: Male or female
4. Patients who can be monitored for at least 2 years after surgery
(Patients who can undergo follow-up angiography 2 years after surgery)
Lesion criteria
1. Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented
The inferior and superior poles of the superficial femoral artery are defined as the overlap with the bone in the adductor canal in the upper part of the femur, and the origin of the bifurcation, respectively.
2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
In addition, patients with bilateral lesions or aorta-iliac artery lesions may be included. In patients with bilateral lesions, endovascular therapy should be conducted for each limb at an interval of 30 to 45 days.
3. Occlusive lesions may be included.
Key exclusion criteria
Exclusion criteria
Patient criteria
Patients who meet any of the following criteria should be excluded from the study:
1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency
*Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated.
2.Patients with congestive cardiac failure (NYHA III or IV or EF<30%)
3.Patients with a drug-eluting stent (DES)
4.Patients with creatinine of 2 mg/dL or 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.
5.Pregnant or potentially pregnant women
6.Patients with acute lower limb ischemia
7.Patients who are not eligible for the study in the opinion of the attending physician.
Lesion criteria
Lesions that meet any of the following criteria should be excluded from the study:
1.Remnant inflow (aorta-iliac artery lesion)
2.Severe calcification (lesions not expected to be appropriately expanded)
3.No arterial runoff below the knee
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
Division name
Internal medicine department
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, Hyogo 660-8511, Japan
TEL
06-6416-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hosp
Division name
Internal medicine department
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, Hyogo 660-8511, Japan
TEL
06-6416-1221
Homepage URL
Sponsor or person
Institute
Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hosp
Institute
Department
Personal name
Funding Source
Organization
Association for Establishment of Evidence in Interventions.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00912756
Org. issuing International ID_1
Clinical Trails.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2008 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 18 | Day |
Last modified on
| 2009 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002524
