Diabetes MellitusPhase 4NCT05322200
The POST-ACS Study
A Phase 4 study testing A computerized tomography (CT) coronary angiogram, Vicorder (Skidmore medical, UK) and Blood tests for inflammation and oxidative stress markers in people with Diabetes Mellitus and Acute Coronary Syndrome, run by Swansea Bay University Health Board at 1 site in United Kingdom.
Trial summary
Individuals with T2DM have a two-fold excess risk of cardiovascular (CV) events compared with their non-diabetic counterparts. Although it is the primary cause of death in T2DM, there is no significant evidence that intensive glucose lowering reduces CV events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- A computerized tomography (CT) coronary angiogram, Vicorder (Skidmore medical, UK) and Blood tests for inflammation and oxidative stress markers
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2022to 1 Aug 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c > 5.7% (39 mmol/mol)
- Patients presented with a clinical diagnosis of ACS comprising detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:
- Symptoms of acute myocardial ischemia;
- New ischemic electrocardiographic (ECG) changes (ST-T wave changes or new LBBB);
- Development of pathological Q waves;
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic aetiology;
- Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy
Who cannot join
- Type 1 DM
- Left ventricular ejection fraction <40%
- Heart failure classified as being in New York Heart Association (NYHA) Class III-IV.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation.
- History of renal insufficiency with estimated glomerular filtration rate <30mL/min/1.73m2
- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Show all 11Show fewer
- History of treatment with GLP-1 within 90 days before screening
- Current use of SGLT-2 inhibitors within 30 days of screening
- Known or suspected hypersensitivity to Semaglutide or related products.
- Female who is pregnant, breastfeeding or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
- Current enrolment in any other clinical trial within 30 days from screening
Trial locations and contacts
1 site in 1 country.
Kathie Wareham contact
United Kingdom1 site, 1 recruiting
- Recruiting
Swansea Bay University Health Board
Swansea, SA2 8QA
Ahmed Salem
Ahmed Salem
About this study
Official title: Potential Impact of Oral Semaglutide on Coronary Artery Disease Progression Following Acute Coronary Syndrome: The POST-ACS Study
Individuals with T2DM have a two-fold excess risk of cardiovascular (CV) events compared with their non-diabetic counterparts.
Although it is the primary cause of death in T2DM, there is no significant evidence that intensive glucose lowering reduces CV events. Multiple Cardiovascular Outcome Trials have suggested CV safety and benefit with the new class hypoglycemic agents - glucagon-like peptide 1 receptor agonists (GLP-RAs) in patients with DM and a high CV risk profile with a mechanism not directly dependent on their glucose-lowering effect. Varies theories regarding the mechanism of action of GLP-RAs on reducing CV events have been proposed, including reducing inflammation, protection of ischemia/reperfusion injury, and improvement in endothelial dysfunction but the effects of these new agents on in-vivo atherosclerotic plaque burden is currently unproven.
Read more
The investigators hypothesize that compared with placebo, 1-year treatment with the oral GLP-RA "Semaglutide" will result in a regression of necrotic core within potentially vulnerable coronary plaques (identified using the novel method "Plaque Maps" analysis on CT Coronary Angiography) in patients with raised HbA1c (>5.7%) after acute coronary syndromes (ACS).
Methods: One hundred forty patients admitted with ACS and have raised HbA1c >5.7% will be enrolled in the trial and randomized in a 1:1 blinded fashion to receive conventional therapy and initiation of Semaglutide or conventional therapy plus placebo.
All patients will have a CT Coronary Angiography with Plaque Map analysis of atherosclerotic burden, plaque composition and presence of potentially vulnerable plaque morphology at baseline prior to therapy initiation and following 12 months of treatment. In addition, to help elucidate the potential mechanisms of any anti-atherosclerotic effects, patients will have a non-invasive assessment of vascular function assessed by aortic pulse wave velocity and comprehensive biomarker analysis of inflammation, atherogenesis and oxidative stress.
- Being tested
- A computerized tomography (CT) coronary angiogram, Vicorder (Skidmore medical, UK), Blood tests for inflammation and oxidative stress markers
- Medical subject headings
- Diabetes Mellitus, Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A computerized tomography (CT) coronary angiogramRadiation
Participants in both arms will undergo CT coronary angiogram with Plaque Map analysis at baseline prior to therapy initiation and following 12 months of treatment.
Vicorder (Skidmore medical, UK)Procedure or surgery
Participants in both arms will undergo aortic carotid-femoral pulse wave velocity (cfPWV)through the Vicorder (Skidmore medical, UK), which uses oscillometric cuff-based measurements to establish the index of arterial stiffness. The procedure will be done at baseline and 12 months after therapy initiation.
Blood tests for inflammation and oxidative stress markersOther
All the participants will have (non-fasting) blood samples performed to assess serum glucose, lipid profile and serum biomarkers for plaque initiation (Lipid profile, LpPLA2), endothelial activation (MCP-1), plaque inflammation (hsCRP, IL6, IL18, TNF, advanced glycation end-products), vulnerable transformation (vEGF, PAI-1, BMP-6) and measures of oxidative stress (Ox-LDL, TAOS, TBARs) at baseline, and at 12 months after therapy initiation
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | Oral Semaglutide + conventional therapy (includes dual antiplatelets, Statin, Angiotensin-converting enzyme inhibitors (ACE inhibitors) and beta-blockers) Receives: Radiation: A computerized tomography (CT) coronary angiogram; Procedure: Vicorder (Skidmore medical, UK); Other: Blood tests for inflammation and oxidative stress markers |
| Placebo | Placebo comparator | placebo (same dose and administration route) + conventional therapy (includes dual antiplatelets, Statin, Angiotensin-converting enzyme inhibitors (ACE inhibitors) and beta-blockers) Receives: Radiation: A computerized tomography (CT) coronary angiogram; Procedure: Vicorder (Skidmore medical, UK); Other: Blood tests for inflammation and oxidative stress markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the regression of vulnerable coronary plaque (necrotic core) assessed using histologically validated "Plaque Maps" derived from CT Coronary angiography in patients with raised HbA1c admitted with ACS and treated with oral Semaglutide or placebo.
Reduction in mean coronary plaque necrotic core (%) identified by CT Coronary Angiography Plaque Maps after 12-month therapy (Semaglutide or placebo).
Measured: 12 months
Secondary outcomes (4)
-Evaluate the effect of oral Semaglutide on atherosclerotic plaque burden.
Compare the regression (or progression) of vulnerable coronary plaque burden (%) assessed by CTCA in patients treated with oral Semaglutide or placebo for 12 months.
Measured: 12 months
Evaluate the effect of oral Semaglutide on levels of biomarkers of inflammation.
Assess the changes in levels of serum biomarkers for inflammation (inflammation (hsCRP, IL6, IL18, TNF, advanced glycation end-products) at baseline, and at 12 months after therapy initiation (Drug vs placebo).
The biomarkers will be calculated on the whole as one outcome. i.e. if the majority of the biomarkers are decreasing with the use of oral Semaglutide , this will count as a positive outcome and vice versa.
Every biomarker value will be recorded in the trial before and after the follow-up period
Measured: 12 months
-Evaluate any potential effect of oral Semaglutide on arterial stiffness
Assess the changes in arterial stiffness by calculating aortic carotid-femoral pulse wave velocity (cfPWV) through the Vicorder (Skidmore medical, UK) at baseline, and at 12 months after therapy initiation (Drug vs placebo).
Measured: 12 months
Evaluate the effect of oral Semaglutide on levels of biomarkers of oxidative stress.
Assess the changes in levels of serum biomarkers for oxidative stress (Ox-LDL, TAOS, TBARs) at baseline, and at 12 months after therapy initiation (Drug vs placebo).
The biomarkers will be calculated on the whole as one outcome. i.e. if the majority of the biomarkers are decreasing with the use of oral Semaglutide , this will count as a positive outcome and vice versa.
Every biomarker value will be recorded in the trial before and after the follow-up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start31 Aug 2022
- Primary completion28 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322200
- Sponsor's protocol ID
- 275165
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Impact of Oral Semaglutide on Coronary Artery Disease Progression Following Acute Coronary Syndrome: The POST-ACS Study
- ClinicalTrials.gov ID
- NCT05322200
- Acronym / sponsor ID
- 275165
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Apr 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.
Individuals with T2DM have a two-fold excess risk of cardiovascular (CV) events compared with their non-diabetic counterparts.
Although it is the primary cause of death in T2DM, there is no significant evidence that intensive glucose lowering reduces CV events. Multiple Cardiovascular Outcome Trials have suggested CV safety and benefit with the new class hypoglycemic agents - glucagon-like peptide 1 receptor agonists (GLP-RAs) in patients with DM and a high CV risk profile with a mechanism not directly dependent on their glucose-lowering effect. Varies theories regarding the mechanism of action of GLP-RAs on reducing CV events have been proposed, including reducing inflammation, protection of ischemia/reperfusion injury, and improvement in endothelial dysfunction but the effects of these new agents on in-vivo atherosclerotic plaque burden is currently unproven.
The investigators hypothesize that compared with placebo, 1-year treatment with the oral GLP-RA "Semaglutide" will result in a regression of necrotic core within potentially vulnerable coronary plaques (identified using the novel method "Plaque Maps" analysis on CT Coronary Angiography) in patients with raised HbA1c (>5.7%) after acute coronary syndromes (ACS).
Methods: One hundred forty patients admitted with ACS and have raised HbA1c >5.7% will be enrolled in the trial and randomized in a 1:1 blinded fashion to receive conventional therapy and initiation of Semaglutide or conventional therapy plus placebo.
All patients will have a CT Coronary Angiography with Plaque Map analysis of atherosclerotic burden, plaque composition and presence of potentially vulnerable plaque morphology at baseline prior to therapy initiation and following 12 months of treatment. In addition, to help elucidate the potential mechanisms of any anti-atherosclerotic effects, patients will have a non-invasive assessment of vascular function assessed by aortic pulse wave velocity and comprehensive biomarker analysis of inflammation, atherogenesis and oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Radiation: A computerized tomography (CT) coronary angiogram, Procedure: Vicorder (Skidmore medical, UK), Other: Blood tests for inflammation and oxidative stress markersOral Semaglutide + conventional therapy (includes dual antiplatelets, Statin, Angiotensin-converting enzyme inhibitors (ACE inhibitors) and beta-blockers) |
| Placebo | Placebo comparator | Radiation: A computerized tomography (CT) coronary angiogram, Procedure: Vicorder (Skidmore medical, UK), Other: Blood tests for inflammation and oxidative stress markersplacebo (same dose and administration route) + conventional therapy (includes dual antiplatelets, Statin, Angiotensin-converting enzyme inhibitors (ACE inhibitors) and beta-blockers) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HbA1c > 5.7% (39 mmol/mol)
- Patients presented with a clinical diagnosis of ACS comprising detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:
Key exclusion criteria (11 listed)
- Type 1 DM
- Left ventricular ejection fraction <40%
- Heart failure classified as being in New York Heart Association (NYHA) Class III-IV.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation.
- History of renal insufficiency with estimated glomerular filtration rate <30mL/min/1.73m2
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 |
|---|---|---|
| A computerized tomography (CT) coronary angiogramParticipants in both arms will undergo CT coronary angiogram with Plaque Map analysis at baseline prior to therapy initiation and following 12 months of treatment. | Radiation | Active drug, Placebo |
| Vicorder (Skidmore medical, UK)Participants in both arms will undergo aortic carotid-femoral pulse wave velocity (cfPWV)through the Vicorder (Skidmore medical, UK), which uses oscillometric cuff-based measurements to establish the index of arterial stiffness. The procedure will be done at baseline and 12 months after therapy initiation. | Procedure or surgery | Active drug, Placebo |
| Blood tests for inflammation and oxidative stress markersAll the participants will have (non-fasting) blood samples performed to assess serum glucose, lipid profile and serum biomarkers for plaque initiation (Lipid profile, LpPLA2), endothelial activation (MCP-1), plaque inflammation (hsCRP, IL6, IL18, TNF, advanced glycation end-products), vulnerable transformation (vEGF, PAI-1, BMP-6) and measures of oxidative stress (Ox-LDL, TAOS, TBARs) at baseline, and at 12 months after therapy initiation | Other | Active drug, Placebo |
Primary outcome
Compare the regression of vulnerable coronary plaque (necrotic core) assessed using histologically validated "Plaque Maps" derived from CT Coronary angiography in patients with raised HbA1c admitted with ACS and treated with oral Semaglutide or placebo.
Time frame: 12 months
Reduction in mean coronary plaque necrotic core (%) identified by CT Coronary Angiography Plaque Maps after 12-month therapy (Semaglutide or placebo).
4 secondary outcomes
-Evaluate the effect of oral Semaglutide on atherosclerotic plaque burden.
Time frame: 12 months
Evaluate the effect of oral Semaglutide on levels of biomarkers of inflammation.
Time frame: 12 months
-Evaluate any potential effect of oral Semaglutide on arterial stiffness
Time frame: 12 months
Evaluate the effect of oral Semaglutide on levels of biomarkers of oxidative stress.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Kathie Wareham contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A computerized tomography (CT) coronary angiogram, Vicorder (Skidmore medical, UK) and Blood tests for inflammation and oxidative stress markers in people with Diabetes Mellitus and Acute Coronary Syndrome, run by Swansea Bay University Health Board at 1 site in United Kingdom.
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 7 inclusion and 11 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmed Salem, MBBS (07449959899, dr.ahmedsalem11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the regression of vulnerable coronary plaque (necrotic core) assessed using histologically validated "Plaque Maps" derived from CT Coronary angiography in patients with raised HbA1c admitted with ACS and treated with oral Semaglutide or placebo. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.