Peripheral Arterial DiseasePhase 4NCT02959606
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study
A Phase 4 study testing Sarpogrelate SR 300mg and Clopidogrel in people with Peripheral Arterial Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Sarpogrelate SR 300mg and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, >18 years old
- Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis
- Successful FP intervention; residual stenosis <30%
- Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)
- patent outflow status; at least 1 arterial runoff in below knee arteries
- All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A~ D
Who cannot join
- At risk of hemorrhage, bleeding tendency or thrombophilia
- Acute limb ischemia / inflammatory arterial disease
- Contraindication or allergic to ASA, clopidogrel, Anplone
- Medication of warfarin
- Pregnancy, hepatic dysfunction, thrombocytopenia
- Previous FP bypass or intervention
- Impossible to stop clopidogrel before EVT
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seung-Kee Min,
Seoul, 110-744
Seung-Kee Min, MD., +82.2-2072-0297, skminmd@snuh.org
About this study
Official title: SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Sarpogrelate SR 300mg, Clopidogrel
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarpogrelate SR 300mgDrug
Also called Anplone SR
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate SR 300mg + ASA | Experimental | Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.
Other Name: Anplone SR Receives: Drug: Sarpogrelate SR 300mg |
| Clopidogrel + ASA | Active comparator | Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.
Other Name: Plavix Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis rate (50%>) in 6 months by CT angiography
Measured: 6 months
Secondary outcomes (5)
Target lesion restenosis(TLR) in 6 months
Measured: 6 months
Major bleeding complication
Measured: 6 months
Ipsilateral major amputation
Measured: 6 months
All-cause mortality
Measured: 6 months
All adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Kee Min, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959606
- Sponsor's protocol ID
- SAFE
- Status last verified
- Jul 2017
- First submitted
- 8 Nov 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
Publications
Han A, Lee T, Lee J, Song SW, Lee SS, Jung IM, Kang JM, Gwon JG, Yun WS, Cho YP, Ko H, Park YJ, Min SK. A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention. Sci Rep. 2023 Feb 13;13(1):2502. doi: 10.1038/s41598-023-29006-z.
PubMed 36781928Ahn S, Lee J, Min SK, Ha J, Min SI, Kim SY, Cho MJ, Cho S; SAFE study investigators. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials. 2017 Sep 22;18(1):439. doi: 10.1186/s13063-017-2155-5.
PubMed 28938905
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02959606
- Acronym / sponsor ID
- SAFE
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate SR 300mg + ASA | Experimental | Drug: Sarpogrelate SR 300mgSarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Anplone SR |
| Clopidogrel + ASA | Active comparator | Drug: ClopidogrelClopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Plavix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult, >18 years old
- Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis
- Successful FP intervention; residual stenosis <30%
- Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)
- patent outflow status; at least 1 arterial runoff in below knee arteries
Key exclusion criteria (7 listed)
- At risk of hemorrhage, bleeding tendency or thrombophilia
- Acute limb ischemia / inflammatory arterial disease
- Contraindication or allergic to ASA, clopidogrel, Anplone
- Medication of warfarin
- Pregnancy, hepatic dysfunction, thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarpogrelate SR 300mgAlso: Anplone SR | Drug | Sarpogrelate SR 300mg + ASA |
| Clopidogrel | Drug | Clopidogrel + ASA |
Primary outcome
Restenosis rate (50%>) in 6 months by CT angiography
Time frame: 6 months
5 secondary outcomes
Target lesion restenosis(TLR) in 6 months
Time frame: 6 months
Major bleeding complication
Time frame: 6 months
Ipsilateral major amputation
Time frame: 6 months
All-cause mortality
Time frame: 6 months
All adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Derived from this study: PubMed 36781928Han A, Lee T, Lee J, Song SW, Lee SS, Jung IM, Kang JM, Gwon JG, Yun WS, Cho YP, Ko H, Park YJ, Min SK. A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention. Sci Rep. 2023 Feb 13;13(1):2502. doi: 10.1038/s41598-023-29006-z.
- Derived from this study: PubMed 28938905Ahn S, Lee J, Min SK, Ha J, Min SI, Kim SY, Cho MJ, Cho S; SAFE study investigators. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials. 2017 Sep 22;18(1):439. doi: 10.1186/s13063-017-2155-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sarpogrelate SR 300mg and Clopidogrel in people with Peripheral Arterial Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Kee Min, MD.PhD. (+82.2-2072-0297, skminmd@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restenosis rate (50%>) in 6 months by CT angiography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959606, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.