Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy

NCT05553717 | Unknown

• 1 other identifier: carvedilol as Gastroprotective
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the possible efficacy of Carvedilol as gastroprotective agent against aspirin-induced upper gastro-intestinal complications in patients with ischemic heart disease (IHD).

Conditions

IHD; Gastro-Intestinal Disorder; Aspirin Induced Esophageal Ulcer

Outcome Measures

Primary Outcomes (2)

• Evaluation the change in gastrointestinal symptoms.

  improve gastrointestinal symptoms by assessment the change in SAGIS questionnaire

  3 months

• Quality of life of IHD patients

  Improve quality of life according SAQ-7 questionair

  3 months

Secondary Outcomes (4)

• the changes in the measured biomarkers

  3 months

• Change in PGE2

  3 months

• Change in Gastrin-17 serum .

  3 months

• Malondialdehyde (MDA) serum level

  3months

Study Arms (2)

group 1

ACTIVE COMPARATOR

33 patients who will receive aspirin 150mg + carvedilol 12.5mg twice daily plus other traditional therapy of ischemia for three months.

Drug: Carvedilol

group 2 control

NO INTERVENTION

33 patients who will receive aspirin 150mg + Captopril 12.5mg twice daily plus other traditional therapy of ischemia for three months.

Interventions

Carvedilol DRUG

Carvedilol 12.5mg\\12hr

group 1

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-60 years.
• Both genders.
• Patient with IHD including myocardial infarction, unstable angina and chronic stable angina on aspirin therapy.
• Patients with hypertension.
• Patients on low dose aspirin therapy for at least 3 months.

You may not qualify if:

• Subjects with history of gastrointestinal disease, gastroduodenal surgery, H. pylori infection.
• History or current diagnosis of major depressive disorder or other psychiatric disorders.
• Patients already under histamine-2 receptor antagonist, proton pump inhibitor, misoprostol or gastrofate within 2 weeks of entering this study.
• Patients who are allergic to aspirin and NSAIDs, who have an intolerance to aspirin and NSAIDs.
• Subjects with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.
• Pregnancy or lactation.
• Patients with severe hepatic impairment (Child-Pugh class B and C) or total bilirubin level ≥ 1.2 mg/dl.
• Patients with renal impairment (creatinine clearance less than 50mg/dl).

Sponsors & Collaborators

• Tanta University: lead

Related Publications (10)

• Kavitt RT, Lipowska AM, Anyane-Yeboa A, Gralnek IM. Diagnosis and Treatment of Peptic Ulcer Disease. Am J Med. 2019 Apr;132(4):447-456. doi: 10.1016/j.amjmed.2018.12.009. Epub 2019 Jan 3.

  PMID: 30611829 BACKGROUND

• Patrono C, Baigent C. Role of aspirin in primary prevention of cardiovascular disease. Nat Rev Cardiol. 2019 Nov;16(11):675-686. doi: 10.1038/s41569-019-0225-y. Epub 2019 Jun 26.

  PMID: 31243390 BACKGROUND

• Cadavid AP. Aspirin: The Mechanism of Action Revisited in the Context of Pregnancy Complications. Front Immunol. 2017 Mar 15;8:261. doi: 10.3389/fimmu.2017.00261. eCollection 2017.

  PMID: 28360907 BACKGROUND

• Chitapanarux T, Lertprasertsuke N, Kongnak A. Teprenone for the prevention of low-dose aspirin-induced gastric mucosal injury in Helicobacter pylori-negative patients. Scand J Gastroenterol. 2019 Oct;54(10):1199-1204. doi: 10.1080/00365521.2019.1672781. Epub 2019 Oct 8.

  PMID: 31591940 BACKGROUND

• Valkhoff VE, Sturkenboom MC, Hill C, Veldhuyzen van Zanten S, Kuipers EJ. Low-dose acetylsalicylic acid use and the risk of upper gastrointestinal bleeding: a meta-analysis of randomized clinical trials and observational studies. Can J Gastroenterol. 2013 Mar;27(3):159-67. doi: 10.1155/2013/596015.

  PMID: 23516680 BACKGROUND

• Osman AS, Labib DA, Kamel MM. Carvedilol can attenuate histamine-induced paw edema and formaldehyde-induced arthritis in rats without risk of gastric irritation. Int Immunopharmacol. 2017 Sep;50:243-250. doi: 10.1016/j.intimp.2017.07.004. Epub 2017 Jul 12.

  PMID: 28711030 BACKGROUND

• Ahmed I, Elkablawy MA, El-Agamy DS, Bazarbay AA, Ahmed N. Carvedilol safeguards against aspirin-induced gastric damage in rats. Hum Exp Toxicol. 2020 Sep;39(9):1257-1267. doi: 10.1177/0960327120918306. Epub 2020 Apr 15.

  PMID: 32295429 BACKGROUND

• Koloski NA, Jones M, Hammer J, von Wulffen M, Shah A, Hoelz H, Kutyla M, Burger D, Martin N, Gurusamy SR, Talley NJ, Holtmann G. The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting. Dig Dis Sci. 2017 Aug;62(8):1913-1922. doi: 10.1007/s10620-017-4599-6. Epub 2017 May 27.

  PMID: 28551709 BACKGROUND

• Gierlaszynska K, Pudlo R, Jaworska I, Byrczek-Godula K, Gasior M. Tools for assessing quality of life in cardiology and cardiac surgery. Kardiochir Torakochirurgia Pol. 2016 Mar;13(1):78-82. doi: 10.5114/kitp.2016.58974. Epub 2016 Mar 30.

  PMID: 27212988 BACKGROUND

• Elkablawy SM, Shaban AE, Mostafa TM. Clinical study evaluating the gastroprotective effect of carvedilol in patients with ischemic heart disease on aspirin therapy. Inflammopharmacology. 2025 Nov;33(11):6831-6838. doi: 10.1007/s10787-025-01961-1. Epub 2025 Sep 30.

  PMID: 41028410 DERIVED

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacy master candidate

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 23, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09