IHDNCT05553717
Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy
A study testing Carvedilol in people with IHD and Gastro-Intestinal Disorder, run by Tanta University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- IHD, Gastro-Intestinal Disorder, Aspirin Induced Esophageal Ulcer
- What is being tested?
- Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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).
Read the 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.
- Being tested
- Carvedilol
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Carvedilol 12.5mg\12hr
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the change in gastrointestinal symptoms.
improve gastrointestinal symptoms by assessment the change in SAGIS questionnaire
Measured: 3 months
Quality of life of IHD patients
Improve quality of life according SAQ-7 questionair
Measured: 3 months
Secondary outcomes (4)
the changes in the measured biomarkers
Hydroxynonenal serum level , high level indicate gastric ulcer , using commercially available ELISA kit.
Measured: 3 months
Change in PGE2
High level of PGE2 indicate gastric mucosa integrity,using commercially available ELISA kit.
Measured: 3 months
Change in Gastrin-17 serum .
Low level of gastrin-17 indicate high acid output ,using commercially available ELISA kit.
Measured: 3 months
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).
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IHDStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohamed Elkablawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553717
- Sponsor's protocol ID
- carvedilol as Gastroprotective
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30611829Patrono 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.
PubMed 31243390Cadavid 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.
PubMed 28360907Chitapanarux 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.
PubMed 31591940Valkhoff 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.
PubMed 23516680Osman 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.
PubMed 28711030Ahmed 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.
PubMed 32295429Koloski 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.
PubMed 28551709Gierlaszynska 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.
PubMed 27212988Elkablawy 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.
PubMed 41028410
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Gastroprotective Effect of Carvedilol in Patients With Ischemic Heart Disease on Aspirin Therapy
- ClinicalTrials.gov ID
- NCT05553717
- Acronym / sponsor ID
- carvedilol as Gastroprotective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: Carvedilol33 patients who will receive aspirin 150mg + carvedilol 12.5mg twice daily plus other traditional therapy of ischemia for three months. |
| 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolCarvedilol 12.5mg\12hr | Drug | group 1 |
Primary outcome
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
4 secondary outcomes
the changes in the measured biomarkers
Time frame: 3 months
Change in PGE2
Time frame: 3 months
Change in Gastrin-17 serum .
Time frame: 3 months
Malondialdehyde (MDA) serum level
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 30611829Kavitt 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.
- Background: PubMed 31243390Patrono 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.
- Background: PubMed 28360907Cadavid 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.
- Background: PubMed 31591940Chitapanarux 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.
- Background: PubMed 23516680Valkhoff 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.
- Background: PubMed 28711030Osman 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.
- Background: PubMed 32295429Ahmed 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.
- Background: PubMed 28551709Koloski 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.
- Background: PubMed 27212988Gierlaszynska 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.
- Derived from this study: PubMed 41028410Elkablawy 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.
Related trials for IHD
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol in people with IHD and Gastro-Intestinal Disorder, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the change in gastrointestinal symptoms. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553717, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.