Gastro-Intestinal Disorder Clinical Trial
Official title:
Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy
Verified date | September 2022 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Age 25-60 years. 2. Both genders. 3. Patient with IHD including myocardial infarction, unstable angina and chronic stable angina on aspirin therapy. 4. Patients with hypertension. 5. Patients on low dose aspirin therapy for at least 3 months. Exclusion Criteria: 1. Subjects with history of gastrointestinal disease, gastroduodenal surgery, H. pylori infection. 2. History or current diagnosis of major depressive disorder or other psychiatric disorders. 3. Patients already under histamine-2 receptor antagonist, proton pump inhibitor, misoprostol or gastrofate within 2 weeks of entering this study. 4. Patients who are allergic to aspirin and NSAIDs, who have an intolerance to aspirin and NSAIDs. 5. Subjects with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders. 6. Pregnancy or lactation. 7. Patients with severe hepatic impairment (Child-Pugh class B and C) or total bilirubin level = 1.2 mg/dl. 8. Patients with renal impairment (creatinine clearance less than 50mg/dl). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tanta University |
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Erratum in: Dig Dis Sci. 2017 Jul 8;:. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation the change in gastrointestinal symptoms. | improve gastrointestinal symptoms by assessment the change in SAGIS questionnaire | 3 months | |
Primary | Quality of life of IHD patients | Improve quality of life according SAQ-7 questionair | 3 months | |
Secondary | the changes in the measured biomarkers | Hydroxynonenal serum level , high level indicate gastric ulcer , using commercially available ELISA kit. | 3 months | |
Secondary | Change in PGE2 | High level of PGE2 indicate gastric mucosa integrity,using commercially available ELISA kit. | 3 months | |
Secondary | Change in Gastrin-17 serum . | Low level of gastrin-17 indicate high acid output ,using commercially available ELISA kit. | 3 months | |
Secondary | Malondialdehyde (MDA) serum level | indicator of oxidative stress and can be measured in ulcerative and inflammatory conditions of the gastrointestinal tract, using commercially available method (colorimetric method). | 3months |
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