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Clopidogrel Aspirin Therapy (CAT) Versus Apixiban Aspirin Therapy (AAT) After Lower Limb Revascularization

NCT04168398 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1536

Last updated 2022-07-19

No results posted yet for this study

Summary

the Aim of the work is to compare the effect of CAT (Clopidogrel aspirin therapy) and AAT (Apixiban aspirin therapy) after lower extremity revascularization.

The study will be conducted at the department of vascular surgery in Mansoura university hospitals in a randomized controlled Prospective study over 2 years: 2019-2021. It will include all patients presented to our department fulfilling the ,We revascularize about 5-10 limbs per week and the study will be carried over 30 months; sample size will be 600-1200 patients,The study will be conducted in patients with lower limb ischemia who need revascularization. All Symptomatic peripheral artery disease according to Rutherford stages 3 to 6; will be included Patients with severe groin or limb infection, can't give consent (unconscious) and those with mental or behavioral disorders; will be excluded.

Therapies:CAT (Clopidogrel aspirin therapy) Clopidogrel 75 mg (Plavix 75mg) plus Aspirin 81 mg. AAT (Apixiban aspirin therapy): Apixiban 2.5 twice daily (Eliquis 2.5mg) plus Aspirin 81 mg. Every patient will be followed every week till first month, then every 3 months till 1 years. Hemodynamic improvement was assessed by ankle brachial pressure index (ABI), performed before and after the procedure and every 3 months. Evaluation made by CTA or duplex ultrasonography to determine 1ry and 2ry patency, Coagulation profile (platelet count, INR, prothrombin time and activated partial thromboplastin time). Adverse bleeding complications will be documented

Conditions

  • Ischemia
  • Anticoagulants

Interventions

DRUG

Combination drug

Anticoagulation

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Nshaat A Elsaadany, MSc · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2021-11-01
Completion
2021-11-03
FDA Drug
Yes

Countries

  • Egypt

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 NCT04168398 on ClinicalTrials.gov