AFWARDEN-EgyptNCT07826299
Warfarin Quality, Adherence, Range, Determinants, and Events in Egyptian Rheumatic Heart Disease and Atrial Fibrillation
An observational study of AF, run by Assiut University at 1 site in Egypt.
Trial summary
No Egyptian study has systematically quantified TTR, identified its predictors, or linked anticoagulation quality to clinical outcomes in the RHD-AF population. This knowledge gap directly impairs the ability of Egyptian cardiac centers to design effective anticoagulation clinic models.16 WARDEN-Egypt addresses a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AF
- What is being tested?
- INR, Time in Therapeutic Range and International Normalized Ratio (INR)
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: : 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.
Who may be able to join
- Age ≥18 years
- 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)
- Electrocardiographically or holter-confirmed atrial fibrillation (paroxysmal, persistent, or permanent)
- On warfarin therapy for at least 6 consecutive months prior to enrollment with the intent to continue
- At least 3 recorded INR values in the preceding 12 months in the center's logbook (minimum data requirement for Rosendaal TTR calculation)
- Willingness to attend scheduled follow-up visits for 12 months and to provide written informed consent
Show all 9Show fewer
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Heart Hospital, Assiut, Egypt
Asyut, Asyut Governorate
Assiut university, 208822080150, vp_grad@aun.edu.eg
208822080150, vp_grad@aun.edu.eg
About this study
Official title: Time in Therapeutic Range, Predictors of Poor Anticoagulation Control, and Clinical Outcomes in Egyptian Patients With Rheumatic Heart Disease and Atrial Fibrillation on Warfarin: A Single Center Retrospective-Prospective Cohort Study
No Egyptian study has systematically quantified TTR, identified its predictors, or linked anticoagulation quality to clinical outcomes in the RHD-AF population. This knowledge gap directly impairs the ability of Egyptian cardiac centers to design effective anticoagulation clinic models.16 WARDEN-Egypt addresses a precisely defined evidence gap at zero marginal cost: 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.
Read the detailed description
Rheumatic heart disease (RHD) remains the most prevalent acquired cardiac condition in low- and middle-income countries (LMICs), disproportionately affecting young adults in sub-Saharan Africa, South Asia, and the Middle East.1-3 In Egypt, RHD continues to be a leading cause of cardiac morbidity, particularly among women of reproductive age and rural populations with limited access to primary prophylaxis.4,5 Atrial fibrillation (AF) is among the most frequent and clinically dangerous complications of RHD. Unlike non-valvular AF, RHD-AF carries a substantially higher thromboembolic risk - estimated at five to twenty times that of the general population.6 Mitral stenosis is the dominant lesion predisposing to AF and left atrial thrombus formation. For these patients, anticoagulation with vitamin K antagonists (VKAs) remains the standard of care.7 The INVICTUS trial (2022), the largest randomized controlled trial in RHD-AF, definitively established that warfarin is superior to rivaroxaban in patients with RHD-associated AF. The warfarin arm demonstrated significantly lower rates of the composite primary endpoint (stroke, systemic embolism, myocardial infarction, or death from vascular or unknown cause) compared to rivaroxaban (8.2% vs. 12.2% per 100 patient-years; HR 0.65, 95% CI 0.58-0.73; p<0.001). Direct oral anticoagulants (DOACs) are therefore not recommended in RHD-AF, cementing the central role of warfarin in this population for the foreseeable future.5 Warfarin efficacy is critically dependent on the quality of anticoagulation control, best captured by time in therapeutic range (TTR) - the proportion of time that a patient's INR remains within the target range (typically 2.0-3.0 for RHD-AF). TTR calculated by the Rosendaal linear interpolation method is the accepted standard.9
- Conditions
- AF
- Being tested
- INR, Time in Therapeutic Range, International Normalized Ratio (INR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INRDiagnostic test
The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions
Time in Therapeutic RangeDiagnostic test
The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions
International Normalized Ratio (INR)Diagnostic test
The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints: (1) Mean TTR by Rosendaal linear interpolation; (2) Predictors of poor TTR (TTR <65%)
Measured: 12 months of archived INR data extracted at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AFStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Syacoub, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826299
- Sponsor's protocol ID
- TTR in RHD and AF in egypt
- Acronym
- WARDEN-Egypt
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time in Therapeutic Range, Predictors of Poor Anticoagulation Control, and Clinical Outcomes in Egyptian Patients With Rheumatic Heart Disease and Atrial Fibrillation on Warfarin: A Single Center Retrospective-Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07826299
- Acronym / sponsor ID
- WARDEN-Egypt / TTR in RHD and AF in egypt
- Conditions
- AF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No Egyptian study has systematically quantified TTR, identified its predictors, or linked anticoagulation quality to clinical outcomes in the RHD-AF population. This knowledge gap directly impairs the ability of Egyptian cardiac centers to design effective anticoagulation clinic models.16 WARDEN-Egypt addresses a precisely defined evidence gap at zero marginal cost: 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.
Detailed description
Rheumatic heart disease (RHD) remains the most prevalent acquired cardiac condition in low- and middle-income countries (LMICs), disproportionately affecting young adults in sub-Saharan Africa, South Asia, and the Middle East.1-3 In Egypt, RHD continues to be a leading cause of cardiac morbidity, particularly among women of reproductive age and rural populations with limited access to primary prophylaxis.4,5 Atrial fibrillation (AF) is among the most frequent and clinically dangerous complications of RHD. Unlike non-valvular AF, RHD-AF carries a substantially higher thromboembolic risk - estimated at five to twenty times that of the general population.6 Mitral stenosis is the dominant lesion predisposing to AF and left atrial thrombus formation. For these patients, anticoagulation with vitamin K antagonists (VKAs) remains the standard of care.7 The INVICTUS trial (2022), the largest randomized controlled trial in RHD-AF, definitively established that warfarin is superior to rivaroxaban in patients with RHD-associated AF. The warfarin arm demonstrated significantly lower rates of the composite primary endpoint (stroke, systemic embolism, myocardial infarction, or death from vascular or unknown cause) compared to rivaroxaban (8.2% vs. 12.2% per 100 patient-years; HR 0.65, 95% CI 0.58-0.73; p<0.001). Direct oral anticoagulants (DOACs) are therefore not recommended in RHD-AF, cementing the central role of warfarin in this population for the foreseeable future.5 Warfarin efficacy is critically dependent on the quality of anticoagulation control, best captured by time in therapeutic range (TTR) - the proportion of time that a patient's INR remains within the target range (typically 2.0-3.0 for RHD-AF). TTR calculated by the Rosendaal linear interpolation method is the accepted standard.9
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : 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.
Key inclusion criteria (9 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INRThe International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions | Diagnostic test | – |
| Time in Therapeutic RangeThe International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions | Diagnostic test | – |
| International Normalized Ratio (INR)The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions | Diagnostic test | – |
Primary outcome
Primary Endpoints: (1) Mean TTR by Rosendaal linear interpolation; (2) Predictors of poor TTR (TTR <65%)
Time frame: 12 months of archived INR data extracted at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for AF
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CONVERGE Post-Approval Study (PAS)
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Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AF, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Yacoub, Dr (0201146623011 ext. 0111 0201103, mariamsobhyyakoub@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoints: (1) Mean TTR by Rosendaal linear interpolation; (2) Predictors of poor TTR (TTR <65%) (time frame: 12 months of archived INR data extracted at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.