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Can a blood thinner combo save limbs in diabetes and hypertension?

NCT ID NCT07832578

NEW Disease control Sponsor: King Edward Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 22, 2026

Summary

Researchers compare low-dose rivaroxaban plus aspirin with aspirin alone in adults aged 40 to 70 who have chronic limb-threatening ischemia along with diabetes, hypertension, and high cholesterol. The trial tests whether the combination reduces major limb events like amputation and major cardiovascular events like heart attack and stroke over six months. Participants are randomly assigned to one of the two treatments and monitored for bleeding, wound healing, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-dose rivaroxaban plus aspirin
What this could lead to
If the combination works better than aspirin alone, it could offer a way to reduce limb amputations and heart problems in people with narrowed leg arteries.
What could go wrong
This is an early-phase trial with 78 participants, so results may not hold in larger groups. The combination also carries a risk of bleeding, which researchers monitor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All patients of CLTI managed conservatively * ASA score of 3 or more * Age 40-70 yrs * Diagnosed case of Diabetes mellitus type 2 (HbA1c \>8) * Blood Pressue ( \>130/90 , \<180/100 ) * Hypercholestrolemia (Total cholesterol ≥200 mg/dL ) * ABPI \< 0.6 * Claudication distance \< 100 meters * Provided written informed consent (for prospective or interventional studies) Exclusion Criteria: * Cholesterol \>300mg/dl * HbA1c \>12 mg/dl * Previous amputation or debridement of vascular ulcers * Diagnosed varicose veins * History of SEPS(subfacial endoscopic perforator surgery) * Active bleeding disorder * Recent major surgery (\<1 month) * Renal failure requiring dialysis * Coagulopathy * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

hypertensive disorder limb ischemia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Limb ischemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Hospital Lahore

    RECRUITING

    Lahore, Punjab Province, 54000, Pakistan

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