An Early Phase 1 interventional study of Aspirin tablet and Low-Dose Rivaroxaban Plus Aspirin, in Limb Ischemia, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by King Edward Medical University · Early Phase 1, Interventional, and Treatment
The goal of this **clinical trial** is to compare the effectiveness of **low-dose rivaroxaban plus aspirin versus aspirin alone** in patients aged 40-70 years with **chronic limb-threatening ischemia, diabetes mellitus, hypertension, and hypercholesterolemia**. The main questions it aims to answer are:
Researchers will compare **low-dose rivaroxaban (2.5 mg twice daily) plus aspirin (75-100 mg daily)** with **aspirin alone** to see if combination therapy provides better outcomes over a period of **6 months**.
Participants will:
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
This study's planned enrollment of 78 is close to the median of 74 across 356 interventional studies indexed under Ischemia.
Browse Ischemia studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Aspirin tablet
Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.
Drug: Low-Dose Rivaroxaban Plus Aspirin,
75 mg once daily
Drug pages: Rivaroxaban · Aspirin
Low dose Rivaroxaban 2.5 mg used orally twice a day in combination with Aspirin is a vascular protective dose as described in COMPASS and VOYEGAR PAD trials. This low dose has antithrombotic effect without full anticoagulation ,thus less bleeding risk compared to standard anticoagulant dose.
Major Adverse Limb Events (MALEs)
Time frame: 6 months
Major Adverse Cardiovascular Events
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
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Studies of the drugs tested here: Aspirin · Rivaroxaban
King Edward Medical University