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

Sponsor
Science Valley Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04229264
Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
200
Enrollment
1
Location
2
Arms
27.7
Anticipated Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Jan 9, 2020
Anticipated Primary Completion Date :
Feb 2, 2022
Anticipated Study Completion Date :
May 2, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

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

    Outcome Measures

    Primary Outcome Measures

    1. Restenosis of the treated infrapopliteal artery [12 months]

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

    2. Major amputation [12 months]

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

    3. Clinical driven-target lesion revascularization [12 months]

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

    4. Major cardiovascular events [12 months]

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

    Secondary Outcome Measures

    1. Bleeding [12 months]

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

    2. Healing [12 months]

      Time to total healing measured by the Imitomeasure program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 IAMSPE - Sao Paulo Public Servants Hospital São Paulo Brazil 04039000

    Sponsors and Collaborators

    • Science Valley Research Institute
    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Science Valley Research Institute
    ClinicalTrials.gov Identifier:
    NCT04229264
    Other Study ID Numbers:
    • AGRIPPA/EMRISTA 2018
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Ischemia
    Apixaban
    Clopidogrel

    Study Results

    No Results Posted as of Apr 20, 2021