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

• Status: Recruiting
• Trial end date: 2022-05-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Science Valley Research Institute
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Apixaban; Clopidogrel

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.