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IRCT20231117060086N1 IRCT 2023-11-26 Ahvaz University of Medical Sciences Assessment of the impact of Rivaroxaban in peripheral artery disease (PAD) of the lower extremities Assessment of the impact of Rivaroxaban in patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization to prevent major organ and cardiovascular side effects 2023-12-22 anticipated 112 Complete https://irct.ir/trial/73818 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To create a simple random sequence, two-group web-based randomization (www.graphpad.com) and to hide the random allocation, the method of packet envelopes with random sequence (SNOSE) will be used, several envelopes, preparation, and each of the sequences. The created coincidences are recorded on a card and the cards are placed in the letter envelopes in order. To preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed inside the boxes in order, at the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened in order and the assigned group of that participant, it is revealed, Blinding description: It will be a single-blinded study. The researcher will be blinded about the type of medications, but the patients will be informed. To hide the drugs, they will be placed in a sealed, numbered envelope. The preparation of the envelopes will be done by a person, who will not be involved in the research. 2-3 Peripheral artery disease (PAD) of the lower extremities. Intervention 1: Intervention group; patients will receive 2.5 mg of Rivaroxaban tablet brand name (Axabin, Iran Hormon, Iran) twice a day plus َ100 mg Aspirin tablet (A.S.A, Loghman Pharma, Iran) once a day for 6 months. Intervention 2: Control group: patients will receive 2.5 mg Plavix tablet Brand name (Clopidogrel, Kobel Daru, Iran) twice a day plus َ100 mg Aspirin (A.S.A, Loghman Pharma, Iran) once a day, for 6 months. Yes - There is a plan to make this available What will be shared: All data can be shared after anonymising the patients. When: Access period will start after publishing the results. To whom: Every body Conditions: There is no barrier to access. Where to obtain: Dr. Arman Amoon Email:dr.arman.azmoon2020@gmail.com How to obtain: Requesters can be informed of the final results by sending an email to the researcher and receiving a response within a week. Comments:
public Arman Azmoon
Azadegan St, Ahvazian Ave, Emam Hospital
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3292 3985 dr.arman.azmoon2020@gmail.com Ahvaz University of Medical Sciences scientific Arman Azmoon
Azadegan St, Ahvazian Ave, Emam Hospital
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3292 3985 dr.arman.azmoon2020@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization Age above 50 years 50 years no limit Both Clinical need for systemic anticoagulation I73.9 Peripheral vascular disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group; patients will receive 2.5 mg of Rivaroxaban tablet brand name (Axabin, Iran Hormon, Iran) twice a day plus َ100 mg Aspirin tablet (A.S.A, Loghman Pharma, Iran) once a day for 6 months. Control group: patients will receive 2.5 mg Plavix tablet Brand name (Clopidogrel, Kobel Daru, Iran) twice a day plus َ100 mg Aspirin (A.S.A, Loghman Pharma, Iran) once a day, for 6 months. Status of Pain and lameness. Timepoint: Patients will be followed up for a visit one week, one month, three months and six months after starting the medication. Method of measurement: Clinical examination. Status of heart attack, ischemic stroke, cardiovascular death, acute limb ischemia and limb amputation due to vascular causes. Timepoint: Patients will be followed up for a visit one week, one month, three months and six months after starting the intervention. Method of measurement: Clinical examination. Ahvaz University of Medical Sciences Approved 2022-04-19 Ethics committee of Ahvaz َJundishapur University of Medical Sciences Golestan St. Jundishapur University of medical sciences اهواز Khouzestan Iran (Islamic Republic of)