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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A(combined anticoagulation plus antithrombotic therapy group) | Experimental | group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease. |
|
| Group B( antithrombotic therapy alone group) | Active Comparator | group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG Oral Tablet [Xarelto] | Drug | rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival |
|
| Measure | Description | Time Frame |
|---|---|---|
| ALI | acute limb ischemia | upto 1 year |
| major amputation for vascular reasons | any type of major amputation after revascularivation for PAD | upto 1 year |
| MI | myocardial infarction | upto 1 year |
| ischemic stroke | ischemic stroke | upto 1 year |
| cardiovascular death | death because of cardiovascular events | upto 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
- all patients with PAD candidates for revascularization procedures
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayesha masood, MBBS, FCPS Surgery | Contact | +923059159699 | laparoscopy.6@gmail.com | |
| Muhammad Irfan, MBBS,FCPS Surgery, | Contact | +923339259643 | irfan1373@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital | Recruiting | Rawalpindi | Punjab Province | 46000 | Pakistan |
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6 months from start of study
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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
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participants enrolled in the study and the principal investigator would not be knowing the drug regimens used in group A and Group B participants
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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