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Critical Limb IschemiaPhase 3AGRIPPANCT04229264

Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

A Phase 3 study testing Apixaban, ASA and Clopidogrel 75mg in people with Critical Limb Ischemia, run by Science Valley Research Institute at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Apixaban, ASA and Clopidogrel 75mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteBrazil
Study dates
9 Jan 2020to 2 May 2022
Phase
Phase 3
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

  • Written informed consent.
  • Age>18 years old.
  • Negative serum pregnancy test (in women of childbearing only).
  • Patients submitted to endovascular procedures below-the-knee by not exclusively.
  • Patient understands and is willing and able to comply with the study instructions and follow-up visit.
  • More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).
  • Tissue loss (Rutherford 5).
  • One or more patent vessel of pedal arch.

Who cannot join

  • TASC II D femoral and/or popliteal occlusion.
  • Life expectancy less than 1 year.
  • Allergy or contraindication to apixaban treatment.
  • Allergy or contraindication to dual antiplatelet treatment.
  • Creatinine clearance less than 30mL/min.
  • Planned major amputation before procedure.
Show all 15Show fewer
  • Hybrid procedure (open and endovascular).
  • Use of fibrinolytic in the past 10 days.
  • Known HIV infection.
  • Liver disease (acute or chronic hepatitis and cirrhosis).
  • Drug addiction or alcohol abuse 12 months before the randomization.
  • Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein (ketoconazole, Iitraconazole, ritonavir).
  • Platelets count inferior to 100x109/L.
  • INR more than 1.5.
  • History or condition with high risk of bleeding: Eg. Trauma within 30 days before randomization, gastrointestinal bleeding 6 month before the randomization, intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation, cerebral aneurysm and hypertension without control.

Trial locations and contacts

1 site in 1 country.

Leandro Agati, PhD contact

+5501144688183

agati@svriglobal.com

Brazil1 site, 1 recruiting

  • IAMSPE - Sao Paulo Public Servants Hospital

    São Paulo, 04039000

    Rodrigo B Biagioni, 11981871545, rbbiagioni@gmail.com

    Roberto Sacilotto, PHD

    Recruiting

Other trials in Brazil

About this study

Official title: Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb

This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.

Read the detailed description

This study is a multicentre, parallel-group, prospective, randomized open-label, blinded-endpoint adjudication, proof-of-concept, and exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once-daily for 12 months. In the control group, aspirin 100 mg once-daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.

Being tested
Apixaban, ASA, Clopidogrel 75mg
Keywords
Post-infrapopliteal angioplasty
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

    Oral Apixaban 2.5 mg twice daily for one year

  • ASADrug

    Acetil Salicilic Acid 100mg once daily for one year

  • Clopidogrel 75mgDrug

    Also called Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

    Clopidogrel 75mg once daily for 3 months

Study groups in NCT04229264
Study groupRoleWhat they receive
Control groupActive comparatorAspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
Receives: Drug: ASA; Drug: Clopidogrel 75mg
Apixaban groupExperimentalApixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
Receives: Drug: Apixaban; Drug: ASA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Restenosis of the treated infrapopliteal artery

    Number of patients with absence of flow or >2.4 sistolic index obtained by Duplex Scan

    Measured: 12 months

  2. Major amputation

    Number of patients who underwent amputation of the leg above the ankle

    Measured: 12 months

  3. Clinical driven-target lesion revascularization

    Number of patients who was submitted by reintervention of the treated infrapopliteal artery based on the clinical status

    Measured: 12 months

  4. Major cardiovascular events

    Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death

    Measured: 12 months

Secondary outcomes (2)

  1. Bleeding

    Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria

    Measured: 12 months

  2. Healing

    Time to total healing measured by the Imitomeasure program.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start9 Jan 2020
  3. Primary completion2 Feb 2022 (estimated)
  4. Study completion2 May 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229264
Sponsor's protocol ID
AGRIPPA/EMRISTA 2018
Acronym
AGRIPPA
Status last verified
Apr 2021
First submitted
10 Dec 2019
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferraresi R, Centola M, Ferlini M, Da Ros R, Caravaggi C, Assaloni R, Sganzaroli A, Pomidossi G, Bonanomi C, Danzi GB. Long-term outcomes after angioplasty of isolated, below-the-knee arteries in diabetic patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2009 Mar;37(3):336-42. doi: 10.1016/j.ejvs.2008.12.001. Epub 2008 Dec 27.

    PubMed 19112033

  • Tsetis D, Belli AM. The role of infrapopliteal angioplasty. Br J Radiol. 2004 Dec;77(924):1007-15. doi: 10.1259/bjr/97382129.

    PubMed 15569642

  • Shishehbor MH, Hammad TA, Zeller T, Baumgartner I, Scheinert D, Rocha-Singh KJ. An analysis of IN.PACT DEEP randomized trial on the limitations of the societal guidelines-recommended hemodynamic parameters to diagnose critical limb ischemia. J Vasc Surg. 2016 May;63(5):1311-7. doi: 10.1016/j.jvs.2015.11.042. Epub 2016 Feb 6.

    PubMed 26860642

  • El-Sayed H, Bennett ME, Loh TM, Davies MG. Retrograde Pedal Access and Endovascular Revascularization: A Safe and Effective Technique for High-Risk Patients with Complex Tibial Vessel Disease. Ann Vasc Surg. 2016 Feb;31:91-8. doi: 10.1016/j.avsg.2015.09.015. Epub 2015 Nov 26.

    PubMed 26627317

  • Wu R, Yao C, Wang S, Xu X, Wang M, Li Z, Wang S. Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arterial disease: a meta-analysis of randomized trials. J Vasc Surg. 2014 Jun;59(6):1711-20. doi: 10.1016/j.jvs.2014.03.012.

    PubMed 24836770

  • Silingardi R, Tasselli S, Cataldi V, Moratto R, Gennai S, Coppi G, Marcheselli L, Coppi G. Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia. J Vasc Surg. 2013 Apr;57(4):1006-13. doi: 10.1016/j.jvs.2012.09.080. Epub 2013 Jan 21.

    PubMed 23343667

  • Gutzeit A, Schoch E, Sautter T, Jenelten R, Graf N, Binkert CA. Antegrade access to the superficial femoral artery with ultrasound guidance: feasibility and safety. J Vasc Interv Radiol. 2010 Oct;21(10):1495-500. doi: 10.1016/j.jvir.2010.03.021.

    PubMed 20801678

  • Marcus AJ, Lotzof K, Howard A. Access to the superficial femoral artery in the presence of a "hostile groin": a prospective study. Cardiovasc Intervent Radiol. 2007 May-Jun;30(3):351-4. doi: 10.1007/s00270-005-0347-y.

    PubMed 17295080

  • Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.

    PubMed 23797811

  • Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

    PubMed 16325694

  • Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18.

    PubMed 18372148

  • Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, Gabrielli L, Losa S, Stella A, Gargiulo M, Mantero M, Caminiti M, Ninkovic S, Curci V, Morabito A. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg. 2005 Jun;29(6):620-7. doi: 10.1016/j.ejvs.2005.02.035. Epub 2005 Mar 28.

    PubMed 15878541

  • Nair V, Chaisson G, Abben R. Strategies in infrapopliteal intervention: improving outcomes in challenging patients. J Interv Cardiol. 2009 Feb;22(1):27-36. doi: 10.1111/j.1540-8183.2008.00412.x. No abstract available.

    PubMed 19281520

  • Sumpio BE, Forsythe RO, Ziegler KR, van Baal JG, Lepantalo MJ, Hinchliffe RJ. Clinical implications of the angiosome model in peripheral vascular disease. J Vasc Surg. 2013 Sep;58(3):814-26. doi: 10.1016/j.jvs.2013.06.056.

    PubMed 23972249

  • Sadaghianloo N, Jean-Baptiste E, Declemy S, Mousnier A, Brizzi S, Hassen-Khodja R. Percutaneous angioplasty of long tibial occlusions in critical limb ischemia. Ann Vasc Surg. 2013 Oct;27(7):894-903. doi: 10.1016/j.avsg.2013.02.008.

    PubMed 23993107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban, ASA and Clopidogrel 75mg in people with Critical Limb Ischemia, run by Science Valley Research Institute at 1 site in Brazil.

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 8 inclusion and 15 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 20 Apr 2021. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Leandro Agati, PhD (+5501144688183, agati@svriglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Restenosis of the treated infrapopliteal artery (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT04229264, which also lists 51 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 20 Apr 2021.

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