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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229264
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Science Valley Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Drug: Apixaban Drug: ASA Drug: Clopidogrel 75mg Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : February 2, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control group
Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
 Drug: ASA
Acetil Salicilic Acid 100mg once daily for one year

Drug: Clopidogrel 75mg
Clopidogrel 75mg once daily for 3 months
Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months
Experimental: Apixaban group
Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
 Drug: Apixaban
Oral Apixaban 2.5 mg twice daily for one year
Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

Drug: ASA
Acetil Salicilic Acid 100mg once daily for one year


Outcome Measures
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Primary Outcome Measures :
  1. Restenosis of the treated infrapopliteal artery [ Time Frame: 12 months ]
    Number of patients with absence of flow or >2.4 sistolic index obtained by Duplex Scan

  2. Major amputation [ Time Frame: 12 months ]
    Number of patients who underwent amputation of the leg above the ankle

  3. Clinical driven-target lesion revascularization [ Time Frame: 12 months ]
    Number of patients who was submitted by reintervention of the treated infrapopliteal artery based on the clinical status

  4. Major cardiovascular events [ Time Frame: 12 months ]
    Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 12 months ]
    Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria

  2. Healing [ Time Frame: 12 months ]
    Time to total healing measured by the Imitomeasure program.


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:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
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): NCT04229264


Contacts
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Contact: Leandro Agati, PhD +5501144688183 agati@svriglobal.com

Locations
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Brazil
IAMSPE - Sao Paulo Public Servants Hospital Recruiting
São Paulo, Brazil, 04039000
Contact: Rodrigo B Biagioni    11981871545    rbbiagioni@gmail.com   
Principal Investigator: Roberto Sacilotto, PHD         
Sponsors and Collaborators
Science Valley Research Institute
Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications:
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.

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Responsible Party: Science Valley Research Institute
ClinicalTrials.gov Identifier: NCT04229264    
Other Study ID Numbers: AGRIPPA/EMRISTA 2018
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Science Valley Research Institute:
Post-infrapopliteal angioplasty
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Apixaban
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
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants