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

NCT04229264 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-20

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia

Interventions

DRUG

Apixaban

Oral Apixaban 2.5 mg twice daily for one year

DRUG

ASA

Acetil Salicilic Acid 100mg once daily for one year

DRUG

Clopidogrel 75mg

Clopidogrel 75mg once daily for 3 months

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Science Valley Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2022-02-02
Completion
2022-05-02

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229264 on ClinicalTrials.gov