Clinical trial NCT04994223: Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
Official title: Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Combined Anticoagulation and Antithrombotic Therapy
PAD - Peripheral Arterial Disease
Keywords: rivaroxaban in PAD
Lead sponsor: Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients enrolled in the study would be taken informed consent and divided in two groups, group A receiving rivaroxaban plus aspirin and Group B receiving placebo plus aspirin
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ALI
timeFrame: upto 1 year
measure: major amputation for vascular reasons
timeFrame: upto 1 year
measure: MI
timeFrame: upto 1 year
measure: ischemic stroke
timeFrame: upto 1 year
measure: cardiovascular death
timeFrame: upto 1 year
Secondary outcomes:
measure: thrombolysis in myocardial infarction(TIMI)major bleeding
timeFrame: 2, 30, 180 and 365 days
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Combined Military Hospital
state: Punjab
Study officials:
References: