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

Not yet recruiting

• Conditions: Patients With Atrial Fibrillation Receiving Oral Anticoagulants

• Registration Number: NCT05975320
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study Start: 2023-08
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES	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 .