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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04994223
Other study ID # PAD
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date July 2, 2021
Est. completion date December 30, 2022

Study information

Verified date April 2022
Source Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
Contact Ayesha masood, MBBS, FCPS Surgery
Phone +923059159699
Email laparoscopy.6@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.


Description:

Anticoagulation and antithrombotic therapy is a crucial part of PAD management as it prolongs the patecy of grafts in open surgical revascularization procedures so its proper dosage and duration without increasing risks to the patient and maximizing the benefits is very important. Currently literature in Pakistan regarding this problem couldn't be found so this study would help assessing the outcomes of anticoagulation and antithrombotic therapy in this population with respect to treatment options available and presentation variability of the peripheral arterial disease. Patients with PAD would be enrolled for 6 months and would be followed upto 12 months and then upto 24 months. Eligible subjects will be randomized 1:1 to receive either rivaroxaban 5 mg twice daily plus aspirin 75 mg once daily or rivaroxaban-matching placebo twice daily plus aspirin 75 mg once daily stratified by type of procedure; the treatment assignment will be double-blinded. Randomization and study treatment will begin as soon as possible but no later than 10 days after a successfull lower extremity revascularization. Patients will be prohibited from taking any additional antithrombotic therapy other drugs, including anticoagulants, doses of aspirin >100 mg daily, vorapaxar, ticagrelor, prasugrel, or cilostazol. Enrolled subjects will be having symptomatic PAD defined by evidence of an abnormal ankle-brachial index ≤0.80 in either limb with an anatomy of occlusive disease of involving segments. Subjects would be randomized who had undergone a technically successful endovascular, hybrid, or surgical LER within 10 days and had achieved adequate hemostasis before randomization.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - all patients with PAD candidates for revascularization procedures Exclusion Criteria: 1. planned long-term dual antiplatelet therapy (>6 months), 2. clinical requirement for therapeutic anticoagulation, 3. recent acute limb ischemia or acute coronary syndrome, 4. medical condition that could increase the risk of major bleeding, significantly impaired renal function at baseline (estimated glomerular filtration rate <15 mL•min-1•1.73 m-2), 5. any documented history of intracranial hemorrhage, stroke, or transient ischemic attack

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival

Locations

Country Name City State
Pakistan Combined Military Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary ALI acute limb ischemia upto 1 year
Primary major amputation for vascular reasons any type of major amputation after revascularivation for PAD upto 1 year
Primary MI myocardial infarction upto 1 year
Primary ischemic stroke ischemic stroke upto 1 year
Primary cardiovascular death death because of cardiovascular events upto 1 year
Secondary thrombolysis in myocardial infarction(TIMI)major bleeding combined therapy effect may result in increased bleeding tendency 2, 30, 180 and 365 days
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