Trial | NCT04229264  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
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 Started
Jan 09
2020
Primary Completion
Feb 02
2022
Anticipated
Study Completion
May 02
2022
Anticipated
Last Update
Apr 20
2021

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

Drug Clopidogrel 75mg

Clopidogrel 75mg once daily for 3 months

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

Control group Active Comparator

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

Apixaban group Experimental

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

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.
No Results Posted