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

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ClinicalTrials.gov Identifier: NCT05553717
Recruitment Status : Not yet recruiting
First Posted : September 23, 2022
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Sarah Mohamed Elkablawy, Tanta University

Tracking Information
First Submitted Date  ICMJE September 17, 2022
First Posted Date  ICMJE September 23, 2022
Last Update Posted Date September 23, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2022)
  • Evaluation the change in gastrointestinal symptoms. [ Time Frame: 3 months ]
    improve gastrointestinal symptoms by assessment the change in SAGIS questionnaire
  • Quality of life of IHD patients [ Time Frame: 3 months ]
    Improve quality of life according SAQ-7 questionair
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2022)
  • the changes in the measured biomarkers [ Time Frame: 3 months ]
    Hydroxynonenal serum level , high level indicate gastric ulcer , using commercially available ELISA kit.
  • Change in PGE2 [ Time Frame: 3 months ]
    High level of PGE2 indicate gastric mucosa integrity,using commercially available ELISA kit.
  • Change in Gastrin-17 serum . [ Time Frame: 3 months ]
    Low level of gastrin-17 indicate high acid output ,using commercially available ELISA kit.
  • Malondialdehyde (MDA) serum level [ Time Frame: 3months ]
    indicator of oxidative stress and can be measured in ulcerative and inflammatory conditions of the gastrointestinal tract, using commercially available method (colorimetric method).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy
Official Title  ICMJE Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy
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).
Detailed Description

Gastric ulcer is a common gastrointestinal tract (GIT) disorder that affects about 4 million of the world's population annually, with incidence of complications in approximately 10%-20%. Gastric ulcer impacts negatively on the health-related quality of life of the affected individuals (1). It is characterized by GIT bleeding, perforation, and erosion of the mucosa wall due to imbalance between aggressive factors (acid, pepsin, and Helicobacter pylori) and defensive factors (mucin, prostaglandins (PG), bicarbonate, nitric oxide (NO), mucosal blood flow, and growth factors) (2). Most cases of peptic ulcer disease are associated with Helicobacter pylori infection or the use of nonsteroidal anti-inflammatory drugs (NSAIDs), or both (3). Aspirin or acetylsalicylic acid that has been used as analgesic, antipyretic and antiinflammatory agent against multiple types of inflammation and in the prevention of cardiovascular thrombotic diseases as myocardial infarction (4). Despite its therapeutic benefits, the use of aspirin is a major problem secondary to the associated risk for gastric ulcer (5). Low doses of aspirin were reported to be associated with gastric and duodenal ulcers (6-12). The pathogenesis of aspirin-induced gastric ulceration includes that, the aspirin inhibits the activities of the cyclooxygenase (COX) leading to decrease in prostaglandin (PG) with subsequent reduction in mucus and bicarbonate secretion, decreasing mucosal blood flow, impairment of platelet aggregation, alteration of microvascular structures leading to epithelia damage, increased leukocyte adherence and increased production of inflammatory mediators, reactive oxygen species (ROS) and decreased antioxidant enzymes (13). Enteric-coated aspirin has less gastrointestinal toxicity, but as compared to uncoated formulations, its plasma peak level after oral intake seems slower than traditional formulation (3 to 4 hours vs 15 to 20 minutes). In addition, enteric-coated aspirin is also associated with reduced bioavailability (14). Carvedilol is an antihypertensive agent that is commonly used in the treatment of arterial hypertension, heart failure, and angina pectoris based on its combined β- and α1- blocking activities. its therapeutic benefit also includes its antioxidant and antiperoxidative properties. It has been also shown that, carvedilol acts as a metal scavenger and can protect mitochondria against oxidative damage (15). Furthermore, carvedilol showed anti-oxidative and anti-inflammatory activities against renal, hepato, and cardiotoxicity. Additionally, it is hypothesized that carvedilol has protective effects against aspirin-induced gastric ulcer or gastrointestinal toxicity (16). Very few studies are present regarding the protective effects of Carvedilol on aspirin-induced gastric ulcer. A recent study revealed that, Carvedilol use was associated with an improvement in histopathological pictures of gastric ulcers in animals' model of cold stress ulcer (17).

The previously mentioned findings highlight the need for further studies to evaluate the role of carvedilol as gastroprotective in patient on aspirin therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • IHD
  • Gastro-Intestinal Disorder
  • Aspirin Induced Esophageal Ulcer
Intervention  ICMJE Drug: Carvedilol
Carvedilol 12.5mg\12hr
Study Arms  ICMJE
  • Active Comparator: group 1
    33 patients who will receive aspirin 150mg + carvedilol 12.5mg twice daily plus other traditional therapy of ischemia for three months.
    Intervention: Drug: Carvedilol
  • No Intervention: group 2 control
    33 patients who will receive aspirin 150mg + Captopril 12.5mg twice daily plus other traditional therapy of ischemia for three months.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2022)		 66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05553717
Other Study ID Numbers  ICMJE carvedilol as Gastroprotective
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sarah Mohamed Elkablawy, Tanta University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tanta University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tanta University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP