Patients With Atrial Fibrillation Receiving Oral AnticoagulantsNCT05975320
"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
An observational study of Patients With Atrial Fibrillation Receiving Oral Anticoagulants, run by Sohag University.
Trial summary
Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Atrial Fibrillation Receiving Oral Anticoagulants
- What is being tested?
- Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: -All patients with atrial fibrillation : 1. Aged 18 years old or older . 2. Underwent cardiac valve replacement 3. Who have valvular heart disease receiving anticoagulants . 4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more. 5. Receiving either vitamin K antagonist e.g warfarin or NOAC .
Who may be able to join
- All patients with atrial fibrillation :
- Aged 18 years old or older .
- Underwent cardiac valve replacement
- Who have valvular heart disease receiving anticoagulants .
- Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.
- Receiving either vitamin K antagonist e.g warfarin or NOAC .
Who cannot join
- Patients age less than 18 years old
- Patients receiving anticoagulants without atrial fibrillations
- Pregnant patients with AF
- Patients with AF on Non oral anticoagulants
Trial locations and contacts
No sites are listed yet.
lotfy H Abo Dahab, Professor contact
About this study
Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension.
Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality .
Read more
(AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) .
It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.
- Being tested
- Warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called apixaban, Rivarospire
Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \& (ORBIT) SCORES will be calculated and compared for all cases .
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \& (ORBIT) SCORES will be calculated and compared for all cases .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With Atrial Fibrillation Receiving Oral AnticoagulantsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mohamed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975320
- Sponsor's protocol ID
- Soh-med-23-07-03MS
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.
PubMed 21982650Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.
PubMed 20299623De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis--Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 Dec;110(6):1087-107. doi: 10.1160/TH13-06-0443. Epub 2013 Nov 14.
PubMed 24226379O'Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J. 2015 Dec 7;36(46):3258-64. doi: 10.1093/eurheartj/ehv476. Epub 2015 Sep 29.
PubMed 26424865
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
- ClinicalTrials.gov ID
- NCT05975320
- Acronym / sponsor ID
- Soh-med-23-07-03MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension.
Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality .
(AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) .
It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -All patients with atrial fibrillation : 1. Aged 18 years old or older . 2. Underwent cardiac valve replacement 3. Who have valvular heart disease receiving anticoagulants . 4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more. 5. Receiving either vitamin K antagonist e.g warfarin or NOAC .
Key inclusion criteria (6 listed)
- All patients with atrial fibrillation :
Key exclusion criteria (4 listed)
- Patients age less than 18 years old
- Patients receiving anticoagulants without atrial fibrillations
- Pregnant patients with AF
- Patients with AF on Non oral anticoagulants
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 |
|---|---|---|
| WarfarinAlso: apixaban, RivarospirePatients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \& (ORBIT) SCORES will be calculated and compared for all cases . | Drug | – |
Primary outcome
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
Time frame: 6 months
Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \& (ORBIT) SCORES will be calculated and compared for all cases .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 21982650Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.
- Background: PubMed 20299623Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.
- Background: PubMed 24226379De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis--Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 Dec;110(6):1087-107. doi: 10.1160/TH13-06-0443. Epub 2013 Nov 14.
- Background: PubMed 26424865O'Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J. 2015 Dec 7;36(46):3258-64. doi: 10.1093/eurheartj/ehv476. Epub 2015 Sep 29.
- Individual participant dataSharing planned: Undecided
Related trials for Patients With Atrial Fibrillation Receiving Oral Anticoagulants
RecruitingObservational study
Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion
Atrial Fibrillation (AF), Atrial Fibrillation (Prevention of Stroke)
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. This study is not recruiting at the moment.
lotfy H Abo Dahab, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Atrial Fibrillation Receiving Oral Anticoagulants, run by Sohag University.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen M Al-anwer, Resident (01152631299, yassminmohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975320, which also lists 4 linked publications.
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 3 Aug 2023.