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

April 17, 2021 updated by: Science Valley Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 04039000
        • Recruiting
        • IAMSPE - Sao Paulo Public Servants Hospital
        • Contact:
        • Principal Investigator:
          • Roberto Sacilotto, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: ASA
Acetil Salicilic Acid 100mg once daily for one 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Major amputation
Time Frame: 12 months
Number of patients who underwent amputation of the leg above the ankle
12 months
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
12 months
Major cardiovascular events
Time Frame: 12 months
Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 12 months
Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria
12 months
Healing
Time Frame: 12 months
Time to total healing measured by the Imitomeasure program.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Science Valley Research Institute

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Anticipated)

February 2, 2022

Study Completion (Anticipated)

May 2, 2022

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 17, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGRIPPA/EMRISTA 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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