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Gastrointestinal Bleeding is Blood Loss in the Digestive Tract, Classified as Upper or Lower. Ischemic Heart Disease is Due to Blocked Heart Arteries. Antiplatelet Drugs Help Prevent Heart Attacks But Increase GI Bleeding Risk, Especially When Used Together as Dual Therapy.

Prevalence of Gastrointestinal Bleeding in Ischemic Heart Disease Patients Undergoing Single Compared to Dual Antiplatelet Treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07125651
Enrollment
112
Registered
2025-08-15
Start date
2025-09-01
Completion date
2026-10-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiplatelet Drug-related Gastrointestinal Injury, Antiplatelet Drugs, Gastro Intestinal Bleeding, Ischaemic Heart Diseases

Keywords

Gastrointestinal bleeding, GIB, ischemic heart disease, IHD, Antiplatelet therapy, SAPT, DAPT

Brief summary

Gastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy. This study aims to compare the prevalence and risk of gastrointestinal bleeding in ischemic heart disease patients on single versus dual antiplatelet therapy, and to explore strategies for reducing gastrointestinal bleeding in these patients, enhancing treatment safety without compromising cardiovascular protection.

Detailed description

Gastrointestinal (GI) bleeding refers to blood loss within the gastrointestinal tract, including the esophagus, stomach, small and large intestines, rectum, and anus. It is classified as upper GI bleeding-originating proximal to the ligament of Treitz (esophagus, stomach, first and second parts of the duodenum)-and lower GI bleeding, which originates distal to this ligament (remaining duodenum, jejunum, ileum, colon, rectum, and anus). GI bleeding may be acute, with sudden and severe blood loss, or chronic, involving slow, recurrent bleeding that is less obvious but still clinically significant. Ischemic heart disease (IHD) is caused by reduced blood flow to the heart muscle due to narrowing or blockage of the coronary arteries, mainly from atherosclerosis. This can result in chest pain, heart attacks, and other cardiovascular complications. Antiplatelet drugs, such as aspirin and clopidogrel, inhibit platelet aggregation to prevent blood clots and are essential in IHD management. Single antiplatelet therapy (SAPT) uses one agent, while dual antiplatelet therapy (DAPT) combines two agents for stronger protection against thrombotic events. Both SAPT and DAPT improve cardiovascular outcomes in IHD patients, with SAPT commonly used for long-term prevention and DAPT recommended after acute coronary events or interventions. Antiplatelet drugs, like aspirin and clopidogrel, increase GI bleeding risk by inhibiting platelet aggregation, impairing clot formation, and, in the case of aspirin, directly irritating the stomach lining, making it easier for ulcers or erosions to bleed. The risk is higher with dual therapy. This study aims to compare the prevalence and risk of gastrointestinal bleeding in ischemic heart disease patients on single versus dual antiplatelet therapy, and to explore strategies for reducing gastrointestinal bleeding in these patients, enhancing treatment safety without compromising cardiovascular protection.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients (aged 18 years old and older) who were diagnosed ischemic heart disease on single or dual antiplatelet therapy and developed gastrointestinal bleeding (manifestation of hematemesis, melena or bleeding per rectum).

Exclusion criteria

* Patients on anticoagulant. * Patients with bleeding tendencies. * Individuals with other comorbidities. * patients with acute coronary syndrome. * Uncooperative patients.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatmentBaselineGastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy.

Contacts

Primary ContactAbdulrahman Antar, Resident Doctor
AbdElrahman.17289792@med.aun.edu.eg+201553600089
Backup ContactAbdelhamid Mohamed, Lecturer
Abdon33@aun.edu.eg+201012125291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026