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.

NCT07125651 | Not Yet Recruiting

• 1 other identifier: GIB in IHD patients on APT
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatment

  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.

  Baseline

Eligibility Criteria

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

Study Population

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).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Abraham NS, Hlatky MA, Antman EM, Bhatt DL, Bjorkman DJ, Clark CB, Furberg CD, Johnson DA, Kahi CJ, Laine L, Mahaffey KW, Quigley EM, Scheiman J, Sperling LS, Tomaselli GF; ACCF/ACG/AHA. ACCF/ACG/AHA 2010 Expert Consensus Document on the concomitant use of proton pump inhibitors and thienopyridines: a focused update of the ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation. 2010 Dec 14;122(24):2619-33. doi: 10.1161/CIR.0b013e318202f701. Epub 2010 Nov 8. No abstract available.

  PMID: 21060077 BACKGROUND

• Lanas A, Wu P, Medin J, Mills EJ. Low doses of acetylsalicylic acid increase risk of gastrointestinal bleeding in a meta-analysis. Clin Gastroenterol Hepatol. 2011 Sep;9(9):762-768.e6. doi: 10.1016/j.cgh.2011.05.020. Epub 2011 Jun 6.

  PMID: 21699808 BACKGROUND

• Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2016 Sep 6;68(10):1082-115. doi: 10.1016/j.jacc.2016.03.513. Epub 2016 Mar 29. No abstract available.

  PMID: 27036918 BACKGROUND

• Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

  PMID: 11786451 BACKGROUND

• Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, Perez-Gisbert J, Bujanda L, Castro M, Munoz M, Rodrigo L, Calvet X, Del-Pino D, Garcia S. Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol. 2009 Jul;104(7):1633-41. doi: 10.1038/ajg.2009.164. Epub 2009 May 5.

  PMID: 19574968 BACKGROUND

• Libby P, Theroux P. Pathophysiology of coronary artery disease. Circulation. 2005 Jun 28;111(25):3481-8. doi: 10.1161/CIRCULATIONAHA.105.537878.

  PMID: 15983262 BACKGROUND

• Longstreth GF. Epidemiology and outcome of patients hospitalized with acute lower gastrointestinal hemorrhage: a population-based study. Am J Gastroenterol. 1997 Mar;92(3):419-24.

  PMID: 9068461 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Abdulrahman Antar, Resident Doctor

CONTACT

+201553600089; AbdElrahman.17289792@med.aun.edu.eg

Abdelhamid Mohamed, Lecturer

CONTACT

+201012125291; Abdon33@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08