Overview

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

Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tanta University
Treatments:
Carvedilol
Criteria
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).