Clinical trial NCT05975320: "ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
Official title: "ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patients With Atrial Fibrillation Receiving Oral Anticoagulants
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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 .

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.


Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

1. Patients age less than 18 years old
2. Patients receiving anticoagulants without atrial fibrillations
3. Pregnant patients with AF
4. Patients with AF on Non oral anticoagulants

Primary outcomes:
measure: incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.