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

NCT04229264 | Unknown Phase 3 DMC

• 1 other identifier: AGRIPPA/EMRISTA 2018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia

Keywords

Post-infrapopliteal angioplasty

Outcome Measures

Primary Outcomes (4)

• Restenosis of the treated infrapopliteal artery

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

  12 months

• Major amputation

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

  12 months

• Clinical driven-target lesion revascularization

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

  12 months

• Major cardiovascular events

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

  12 months

Secondary Outcomes (2)

• Bleeding

  12 months

• Healing

  12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.

Drug: ASA; Drug: Clopidogrel 75mg

Apixaban group

EXPERIMENTAL

Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.

Drug: Apixaban; Drug: ASA

Interventions

Apixaban DRUG

Oral Apixaban 2.5 mg twice daily for one year

Also known as: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

Apixaban group

ASA DRUG

Acetil Salicilic Acid 100mg once daily for one year

Apixaban group; Control group

Clopidogrel 75mg DRUG

Clopidogrel 75mg once daily for 3 months

Also known as: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

IAMSPE - Sao Paulo Public Servants Hospital

São Paulo, 04039000, Brazil

RECRUITING

Related Publications (51)

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MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

apixaban; Clopidogrel

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Leandro Agati, PhD

CONTACT

+5501144688183; agati@svriglobal.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 18, 2020
• Study Start: January 9, 2020
• Primary Completion: February 2, 2022
• Study Completion: May 2, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)