Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
NCT ID: NCT04994223
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2021-07-02
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A(combined anticoagulation plus antithrombotic therapy group)
group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease.
Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
Group B( antithrombotic therapy alone group)
group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease.
Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
Interventions
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Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
90 Years
ALL
Yes
Sponsors
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Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
OTHER
Responsible Party
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Ayesha Masood
Trainee in vascular surgery
Locations
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Combined Military Hospital
Rawalpindi, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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muhammad jamil, MBBS, FCPS General Surgery
Role: primary
Other Identifiers
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PAD
Identifier Type: -
Identifier Source: org_study_id
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