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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Oral Apixaban 2.5 mg twice daily for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis of the treated infrapopliteal artery | Number of patients with absence of flow or >2.4 sistolic index obtained by Duplex Scan | 12 months |
| Major amputation | Number of patients who underwent amputation of the leg above the ankle | 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 | 12 months |
| Major cardiovascular events | Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria | 12 months |
| Healing | Time to total healing measured by the Imitomeasure program. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leandro Agati, PhD | Contact | +5501144688183 | agati@svriglobal.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IAMSPE - Sao Paulo Public Servants Hospital | Recruiting | São Paulo | 04039000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19112033 | Background | Ferraresi R, Centola M, Ferlini M, Da Ros R, Caravaggi C, Assaloni R, Sganzaroli A, Pomidossi G, Bonanomi C, Danzi GB. Long-term outcomes after angioplasty of isolated, below-the-knee arteries in diabetic patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2009 Mar;37(3):336-42. doi: 10.1016/j.ejvs.2008.12.001. Epub 2008 Dec 27. | |
| 15569642 |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| ASA | Drug | Acetil Salicilic Acid 100mg once daily for one year |
|
| Clopidogrel 75mg | Drug | Clopidogrel 75mg once daily for 3 months |
|
|
| 12 months |
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| 32730905 | Derived | Biagioni RB, Lopes RD, Agati LB, Sacilotto R, Wolosker N, Sobreira ML, de Freitas Soares BL, Joviliano EE, Bernardi WH, Junior VC, Caffaro RA, Fioranelli A, Van Bellen B, Casella IB, Fidelis RJR, Flumignan RLG, Comerota AJ, Ramacciotti E. Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial. Am Heart J. 2020 Sep;227:100-106. doi: 10.1016/j.ahj.2020.06.010. Epub 2020 Jun 23. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |