Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients. (AGRIPPA)
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ClinicalTrials.gov Identifier: NCT04229264 |
Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : April 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critical Limb Ischemia | Drug: Apixaban Drug: ASA Drug: Clopidogrel 75mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 9, 2020 |
Estimated Primary Completion Date : | February 2, 2022 |
Estimated Study Completion Date : | May 2, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Control group
Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
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Drug: ASA
Acetil Salicilic Acid 100mg once daily for one year Drug: Clopidogrel 75mg Clopidogrel 75mg once daily for 3 months
Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months |
Experimental: Apixaban group
Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
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Drug: Apixaban
Oral Apixaban 2.5 mg twice daily for one year
Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months Drug: ASA Acetil Salicilic Acid 100mg once daily for one year |
- Restenosis of the treated infrapopliteal artery [ Time Frame: 12 months ]Number of patients with absence of flow or >2.4 sistolic index obtained by Duplex Scan
- Major amputation [ Time Frame: 12 months ]Number of patients who underwent amputation of the leg above the ankle
- Clinical driven-target lesion revascularization [ Time Frame: 12 months ]Number of patients who was submitted by reintervention of the treated infrapopliteal artery based on the clinical status
- Major cardiovascular events [ Time Frame: 12 months ]Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death
- Bleeding [ Time Frame: 12 months ]Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria
- Healing [ Time Frame: 12 months ]Time to total healing measured by the Imitomeasure program.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229264
Contact: Leandro Agati, PhD | +5501144688183 | agati@svriglobal.com |
Brazil | |
IAMSPE - Sao Paulo Public Servants Hospital | Recruiting |
São Paulo, Brazil, 04039000 | |
Contact: Rodrigo B Biagioni 11981871545 rbbiagioni@gmail.com | |
Principal Investigator: Roberto Sacilotto, PHD |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Science Valley Research Institute |
ClinicalTrials.gov Identifier: | NCT04229264 |
Other Study ID Numbers: |
AGRIPPA/EMRISTA 2018 |
First Posted: | January 18, 2020 Key Record Dates |
Last Update Posted: | April 20, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Post-infrapopliteal angioplasty |
Ischemia Pathologic Processes Apixaban Clopidogrel Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Anticoagulants |