An Early Phase 1 interventional study of Rivaroxaban 10 MG Oral Tablet [Xarelto] in Combined Anticoagulation and Antithrombotic Therapy and PAD - Peripheral Arterial Disease, sponsored by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi · Early Phase 1, Interventional, and Treatment
EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 60 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease.
Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]
group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease.
Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
ALI
acute limb ischemia
Time frame: upto 1 year
major amputation for vascular reasons
any type of major amputation after revascularivation for PAD
Time frame: upto 1 year
MI
myocardial infarction
Time frame: upto 1 year
ischemic stroke
ischemic stroke
Time frame: upto 1 year
cardiovascular death
death because of cardiovascular events
Time frame: upto 1 year
thrombolysis in myocardial infarction(TIMI)major bleeding
combined therapy effect may result in increased bleeding tendency
Time frame: 2, 30, 180 and 365 days
Plan to share: Yes — title
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi