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

NCT ID: NCT04229264

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2022-05-02

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.

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.

Conditions

Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

ASA

Intervention Type: DRUG

Acetil Salicilic Acid 100mg once daily for one year

Clopidogrel 75mg

Intervention Type: DRUG

Clopidogrel 75mg once daily for 3 months

Apixaban group

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

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Oral Apixaban 2.5 mg twice daily for one year

ASA

Intervention Type: DRUG

Acetil Salicilic Acid 100mg once daily for one year

Interventions

Apixaban

Oral Apixaban 2.5 mg twice daily for one year

Intervention Type: DRUG

ASA

Acetil Salicilic Acid 100mg once daily for one year

Intervention Type: DRUG

Clopidogrel 75mg

Clopidogrel 75mg once daily for 3 months

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Science Valley Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IAMSPE - Sao Paulo Public Servants Hospital

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Leandro Agati, PhD

Role: CONTACT

agati@svriglobal.com

+5501144688183

Facility Contacts

Rodrigo B Biagioni

Role: primary

rbbiagioni@gmail.com

11981871545

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Other Identifiers

AGRIPPA/EMRISTA 2018

Identifier Type: -

Identifier Source: org_study_id