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

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ClinicalTrials.gov Identifier: NCT02959606
Recruitment Status : Unknown
Verified July 2017 by Seung-Kee Min, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2016
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Seung-Kee Min, Seoul National University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Sarpogrelate SR 300mg Drug: Clopidogrel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sarpogrelate SR 300mg + ASA

Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.

Other Name: Anplone SR

 Drug: Sarpogrelate SR 300mg
Other Name: Anplone SR
Active Comparator: Clopidogrel + ASA

Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.

Other Name: Plavix

 Drug: Clopidogrel


Outcome Measures
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Primary Outcome Measures :
  1. Restenosis rate (50%>) in 6 months by CT angiography [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Target lesion restenosis(TLR) in 6 months [ Time Frame: 6 months ]
  2. Major bleeding complication [ Time Frame: 6 months ]
  3. Ipsilateral major amputation [ Time Frame: 6 months ]
  4. All-cause mortality [ Time Frame: 6 months ]
  5. All adverse events [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959606


Contacts
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Contact: Seung-Kee Min, MD.PhD. +82.2-2072-0297 skminmd@snuh.org

Locations
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Korea, Republic of
Seung-Kee Min, Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seung-Kee Min, MD.    +82.2-2072-0297    skminmd@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seung-Kee Min, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02959606    
Other Study ID Numbers: SAFE
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sarpogrelate
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
 Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Serotonin Antagonists
Serotonin Agents