A Phase 3 interventional study of Apixaban and ASA in Critical Limb Ischemia, sponsored by Science Valley Research Institute. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Science Valley Research Institute · Phase 3, Interventional, and Treatment
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.
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Science Valley Research Institute is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
Drug: Apixaban · Drug: ASA
Oral Apixaban 2.5 mg twice daily for one year
Also known as: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months
Acetil Salicilic Acid 100mg once daily for one year
Clopidogrel 75mg once daily for 3 months
Also known as: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months
Restenosis of the treated infrapopliteal artery
Number of patients with absence of flow or \>2.4 sistolic index obtained by Duplex Scan
Time frame: 12 months
Major amputation
Number of patients who underwent amputation of the leg above the ankle
Time frame: 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
Time frame: 12 months
Major cardiovascular events
Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death
Time frame: 12 months
Bleeding
Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria
Time frame: 12 months
Healing
Time to total healing measured by the Imitomeasure program.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia→
Science Valley Research Institute