Role of Frailty in Bleeding Risk Predic… | Clinical Trial

Key information

Conditions

Frailty Acute Coronary Syndrome Bleeding Cardiovascular Diseases Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Potent platelet inhibition reduces the risk of thrombotic complications in patients with acute coronary syndromes. Unavoidably, the more potent platelet inhibition increases the risk of bleeding. Bleeding risk can be predicted using the ARC-HBR criteria, the CRUSADE score, ACUITY score, and PRECISE-DAPT score. These conventional risk scores incorporate clinical, laboratory and procedural variables but often overlook patient centered geriatric parameters such as frailty. Frailty is a multidimensional syndrome characterized by decreased reserves and diminished resistance to stressors. It can be assessed using Rockwoods clinical frailty scale, the frailty index, frailty domains and the Fried scale. The association between frailty and bleeding risk in ACS patients is still inadequately studied. We hypothesize that frailty indices would increase the discriminatory power of established standard bleeding risk scores, and would predict bleeding events among ACS patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment
- Patients must be older than 65 years

Exclusion criteria

- Patients younger than 65 years
- Refusal of participation
- In - hospital death unrelated to bleeding

Treatment and study plan

Primary outcomes

Bleeding Academic Research Consortium ( BARC ) type 3 to 5

Time frame: Baseline

Type 3: Major bleeding (with subtypes) 3a: Overt bleeding plus hemoglobin drop of 3-5 g/dL, or Transfusion with ≤2 units of blood.

3b: Hemoglobin drop ≥5 g/dL, Cardiac tamponade, Bleeding requiring surgical intervention, or Bleeding requiring intravenous vasoactive agents. 3c: Intracranial hemorrhage (excluding microbleeds), Intraocular bleeding compromising vision.

Type 4: CABG-related bleeding Perioperative bleeding within 48 hours of coronary artery bypass grafting (CABG) and Reoperation for bleeding, ≥5 units of blood transfused, Chest tube output ≥2 L in 24 hours, or Cardiac tamponade.

Type 5: Fatal bleeding 5a: Probable fatal bleeding (no autopsy or imaging confirmation). 5b: Definite fatal bleeding (confirmed by autopsy or imaging)

Secondary outcomes

Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2

Time frame: Baseline

Type 0 : no bleeding Type 1: Bleeding that is not actionable and does not require medical attention Type 2 : Any bleeding that requires medical attention, hospitalization, or evaluation by a health care professional. but does not meet criteria for type 3, 4 or 5.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Incremental Value of Frailty Indices in Bleeding Risk Prediction Among Patients With Acute Coronary Syndrome

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2025
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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