UMIN-CTR Clinical Trial

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

Patient with Peripheral Artery Disease

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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 &#61619;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

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

Email

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

Email

Institute

Independent Administrative Institute/Japan Labour Health and Welfare Organization, Kansai Rosai Hosp

Institute

Department

Personal name

Organization

Association for Establishment of Evidence in Interventions.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2009

Year

06

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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