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

  • STATUS
    Recruiting
  • End date
    Feb 2, 2022
  • participants needed
    200
  • sponsor
    Science Valley Research Institute
Updated on 23 January 2021
stenosis
aspirin
endovascular intervention
serum pregnancy test
clopidogrel
ischemia
clopidogrel 75 mg
limb ischemia
endovascular procedure

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.

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.

Details
Condition Critical Limb Ischemia, Critical Limb Ischaemia
Treatment Apixaban, ASA, Clopidogrel 75mg
Clinical Study IdentifierNCT04229264
SponsorScience Valley Research Institute
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Critical Limb Ischemia?
Do you have any of these conditions: Critical Limb Ischaemia or Critical Limb Ischemia?
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
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