SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study

Peripheral Arterial Disease Clinical Trial

Official title:

SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959606
• Other study ID #: SAFE
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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