"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.

NCT05975320 | Unknown

• 1 other identifier: Soh-med-23-07-03MS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Patients With Atrial Fibrillation Receiving Oral Anticoagulants

Outcome Measures

Primary Outcomes (1)

• 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 .

  6 months

Interventions

Warfarin DRUG

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 .

Also known as: apixaban, Rivarospire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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 .

You may qualify if:

• 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 .

You may not qualify if:

• Patients age less than 18 years old
• Patients receiving anticoagulants without atrial fibrillations
• Pregnant patients with AF
• Patients with AF on Non oral anticoagulants

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• 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.

  PMID: 21982650 BACKGROUND

• Pisters 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.

  PMID: 20299623 BACKGROUND

• De 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.

  PMID: 24226379 BACKGROUND

• O'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.

  PMID: 26424865 BACKGROUND

MeSH Terms

Interventions

Warfarin; apixaban

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yasmeen M Al-anwer, Resident

CONTACT

01152631299; yassminmohamed@med.sohag.edu.eg

lotfy H Abo Dahab, Professor

CONTACT

01003459739

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of internal medicine department, Sohag university hospital

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-07