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The clotting test that could reshape warfarin care in egypt

NCT ID NCT07826299

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

People with rheumatic heart disease and atrial fibrillation take warfarin to prevent strokes, but the drug only works safely when blood clotting stays in a narrow target range. Researchers at Assiut University are studying about 90 Egyptian adults on warfarin for at least six months, using their existing INR blood test records to measure how often clotting stays in range. The study also looks for factors that predict poor control and tracks whether poor control links to heart attacks, strokes, or bleeding. The goal is to give Egyptian cardiology centers a benchmark for warfarin quality and clues for improving anticoagulation clinics.

What this could mean

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

What this could lead to
If the study identifies which patients struggle to stay in the safe clotting range, Egyptian heart centers could redesign their warfarin clinics to target those groups and reduce stroke risk.
What could go wrong
This is a small single-center observational study, so its patterns may not apply to other hospitals or countries. It cannot prove that better clinic design prevents strokes, only suggest where to look next.

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.

Participants

About 90 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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.

Who is studied

: the study relies entirely on INR logbooks already maintained in clinical practice and structured follow-up visits that replicate current standard of care. Its findings will provide the first Egyptian TTR benchmark, identify modifiable predictors of poor anticoagulation control amenable to targeted intervention, and generate hypothesis-forming data on the TTR-outcome relationship. This has direct implications for anticoagulation clinic design, national guideline development, and future interventional trials in Egyptian RHD.

Ages

18 years and older

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: * Inclusion Criteria 1. Age ≥18 years 2. Confirmed diagnosis of rheumatic heart disease (echocardiographic evidence of rheumatic valve morphology, prior history of rheumatic fever, or cardiology consultant diagnosis recorded in medical records) 3. Electrocardiographically or holter-confirmed atrial fibrillation (paroxysmal, persistent, or permanent) 4. On warfarin therapy for at least 6 consecutive months prior to enrollment with the intent to continue 5. At least 3 recorded INR values in the preceding 12 months in the center's logbook (minimum data requirement for Rosendaal TTR calculation) 6. Willingness to attend scheduled follow-up visits for 12 months and to provide written informed consent Exclusion Criteria: 1. Anticipated cardiac surgery, valvuloplasty, or cardioversion within the next 6 months 2. Pregnancy or planned pregnancy during the study period 3. Active malignancy or other life-limiting condition with expected survival \<12 months 4. Current or recent (≤12 months) use of a direct oral anticoagulant or heparin as primary anticoagulation 5. Severe hepatic impairment (Child-Pugh C) or known bleeding diathesis 6. Residence in a geographic area making 12-month follow-up participation unreasonably burdensome (as judged by the site investigator) 7. Fewer than 3 documented INR values in the preceding 12 months (insufficient data for Rosendaal TTR calculation) 6. Presence of a mechanical prosthetic heart valve (MPHV) in any position (aortic or mitral), regardless of thrombogenicity category. Patients with bioprosthetic (tissue) valves are not excluded, provided the prescribed INR target is 2.0-3.0 and all other inclusion criteria are met. Patients with mechanical prosthetic heart valves (MPHVs) are excluded from this study. With all enrolled patients having native RHD-AF, a uniform INR therapeutic target of 2.0-3.0 applies to every participant, eliminating patient-specific target adjustments and rendering valve type non-informative as an analytical predictor. The overwhelming majority of warfarin-treated RHD-AF patients at Assiut University Heart Hospital have rheumatic mitral stenosis as the dominant lesion, making this a clinically homogeneous and internally valid study population. Patients with bioprosthetic (tissue) valves on warfarin for AF are not excluded, provided their prescribed INR target is 2.0-3.0 and all other inclusion criteria are satisfied. \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Assiut University Heart Hospital, Assiut, Egypt

    Asyut, Asyut Governorate, Egypt

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