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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02959606
Other study ID # SAFE
Secondary ID
Status Recruiting
Phase Phase 4
First received November 8, 2016
Last updated July 26, 2017
Start date December 2016
Est. completion date January 2019

Study information

Verified date July 2017
Source Seoul National University Hospital
Contact Seung-Kee Min, MD.PhD.
Phone +82.2-2072-0297
Email skminmd@snuh.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent EVT for femoro-popliteal occlusive disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 272
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Adult, >18 years old

2. Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis

3. Successful FP intervention; residual stenosis <30%

4. Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)

5. patent outflow status; at least 1 arterial runoff in below knee arteries

6. All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A~ D

Exclusion Criteria:

1. At risk of hemorrhage, bleeding tendency or thrombophilia

2. Acute limb ischemia / inflammatory arterial disease

3. Contraindication or allergic to ASA, clopidogrel, Anplone

4. Medication of warfarin

5. Pregnancy, hepatic dysfunction, thrombocytopenia

6. Previous FP bypass or intervention

7. Impossible to stop clopidogrel before EVT

Study Design


Intervention

Drug:
Sarpogrelate SR 300mg

Clopidogrel


Locations

Country Name City State
Korea, Republic of Seung-Kee Min, Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Restenosis rate (50%>) in 6 months by CT angiography 6 months
Secondary Target lesion restenosis(TLR) in 6 months 6 months
Secondary Major bleeding complication 6 months
Secondary Ipsilateral major amputation 6 months
Secondary All-cause mortality 6 months
Secondary All adverse events 6 months
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