ACS (Acute Coronary Syndrome)Phase 4DAPA-PCATNCT07351643
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
A Phase 4 study testing Dapagliflozin in people with ACS (Acute Coronary Syndrome) and SGLT2 Inhibitors, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Aged ≥ 18 years, irrespective of gender;
- Meeting the diagnostic criteria for stage 4 CKM syndrome;
- Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;
- Signed informed consent form.
Who cannot join
- Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;
- Severe hepatic dysfunction (Child-Pugh class C);
- History of recurrent urogenital tract infections;
- History of allergy or intolerance to SGLT2 inhibitors;
- Pregnant or lactating women;
- Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg;
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- Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²);
- Participation in other interventional clinical trials;
- Other conditions deemed inappropriate for enrolment by the investigator(s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Yaling Han, MD, +86-24-23922184, cardiology@163.com
About this study
Official title: Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT
The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.
Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.
Read more
The main questions it aims to answer are
- Does dapagliflozin lower coronary artery inflammation as measured by FAI?
- Does dapagliflozin slow the progression of coronary plaques?
Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.
Participants will:
- Undergo percutaneous coronary intervention (PCI) for ACS
- Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone.
- Have a follow-up CCTA scan at 6 months after randomisation.
- Receive follow-up phone calls at 3 and 6 months after randomisation
Read the detailed description
Patients with stage 4 CKM syndrome are individuals who have at least one of excessive/dysfunctional adiposity, other CKM-related risk factors, or chronic kidney disease (CKD), complicated by clinical cardiovascular disease (CVD), including coronary artery disease, heart failure, stroke, peripheral arterial disease, and atrial fibrillation. Stage-4 CKM patients carry an extremely high risk of adverse clinical outcomes. Nearly 80 % of adults in China are at stage 1 or higher of CKM syndrome, among whom patients at stage 4 exhibit a 4-fold higher mortality risk compared with those at stage 0. Representing a very-high-risk population, they are in urgent need of targeted interventions.
Chronic inflammation constitutes the core pathological mechanism underlying CKM progression. Circulating inflammatory biomarkers currently lack sufficient specificity, while PET-CT is costly and poorly accessible, limiting its clinical utility. Studies have demonstrated that fat attenuation index (FAI), calculated by analyzing the radiodensity of pericoronary adipose tissue (PCAT) derived from coronary computed-tomographic angiography (CCTA), enables non-invasive quantification of coronary inflammation. In the setting of arterial inflammation, PCAT loses lipid content with an elevated water-to-lipid ratio, shifting FAI from the lipid-rich phase (approximately -190 HU) toward the water-rich phase (approximately -30 HU). As a novel surrogate inflammatory biomarker, PCAT holds promise as a new therapeutic target for cardiovascular diseases.
Beyond their glucose-lowering and diuretic effects, sodium-glucose cotransporter 2 inhibitors (SGLT2is) exert anti-inflammatory properties, including suppression of inflammatory-cytokine expression and mitigation of oxidative stress. They also reduce the thickness and volume of epicardial adipose tissue (EAT) and dampen its secretion of inflammatory cytokines, which may represent an important pathway mediating their cardiovascular benefits. Nevertheless, existing studies enroll relatively homogeneous populations and do not cover the high-risk stage-4 CKM cohort. Patients with stage-4 CKM have greater EAT burden, and EAT contributes to disease progression. Accordingly, leveraging photon-counting CT, this study aims to explore the modulatory effect of 6-month SGLT2i therapy on local coronary inflammation in stage-4 CKM patients, as well as the association between clinical benefits and alleviated coronary inflammation, so as to provide theoretical evidence for targeted anti-inflammatory therapy in this patient population.
- Conditions
- ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
- Being tested
- Dapagliflozin
- Keywords
- Fat attenuation index, SGLT2 inhibitors, Pericoronary adipose tissue, Residual inflammatory risk, Coronary CT angiography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
10 mg/d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Experimental | Participants receive dapagliflozin 10 mg orally once daily in addition to guideline-directed medical therapy for 6 months. Receives: Drug: Dapagliflozin |
| Non-dapagliflozin group | No intervention | Participants receive guideline-directed medical therapy alone without any SGLT2 inhibitor for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FAI from baseline to 6 months in patients assessed by CCTA
Change in FAI of major coronary arteries (left main [LM], right coronary artery [RCA], left anterior descending [LAD], and left circumflex [LCX]) from baseline to 6 months, expressed in Hounsfield Units (HU), assessed at the patient level.
Measured: From randomization to 6 months post-randomization
Secondary outcomes (6)
Change in total plaque volume
Absolute change in total coronary plaque volume (mm³)
Measured: From randomization to 6 months post-randomization
Change in calcified plaque volume
Absolute change in calcified plaque volume (mm³)
Measured: From baseline (at randomization) to 6 months post-randomization
Change in fibrous plaque volume
Absolute change in fibrous plaque volume (mm³)
Measured: From baseline (at randomization) to 6 months post-randomization
Change in fibrofatty plaque volume
Absolute change in fibrofatty plaque volume (mm³)
Measured: From baseline (at randomization) to 6 months post-randomization
Change in low-attenuation plaque volume
Absolute change in low-attenuation plaque volume (mm³)
Measured: From baseline (at randomization) to 6 months post-randomization
Change in coronary stenosis
Absolute change in degree of coronary artery stenosis (%)
Measured: From baseline (at randomization) to 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies 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
- Model description
- Eligible participants will undergo CCTA at 1 month after PCI. Those meeting all criteria will then be randomized 1:1 to the dapagliflozin group or standard care group using a dynamic block randomization method.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351643
- Sponsor's protocol ID
- SYNH-Y2026172
- Other IDs
- Y(2026)172
- Acronym
- DAPA-PCAT
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT
- ClinicalTrials.gov ID
- NCT07351643
- Acronym / sponsor ID
- DAPA-PCAT / SYNH-Y2026172
- Conditions
- ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
- Keywords
- Fat attenuation index, SGLT2 inhibitors, Pericoronary adipose tissue, Residual inflammatory risk, Coronary CT angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jan 2026 (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 clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.
Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.
The main questions it aims to answer are
- Does dapagliflozin lower coronary artery inflammation as measured by FAI?
- Does dapagliflozin slow the progression of coronary plaques?
Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.
Participants will:
- Undergo percutaneous coronary intervention (PCI) for ACS
- Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone.
- Have a follow-up CCTA scan at 6 months after randomisation.
- Receive follow-up phone calls at 3 and 6 months after randomisation
Detailed description
Patients with stage 4 CKM syndrome are individuals who have at least one of excessive/dysfunctional adiposity, other CKM-related risk factors, or chronic kidney disease (CKD), complicated by clinical cardiovascular disease (CVD), including coronary artery disease, heart failure, stroke, peripheral arterial disease, and atrial fibrillation. Stage-4 CKM patients carry an extremely high risk of adverse clinical outcomes. Nearly 80 % of adults in China are at stage 1 or higher of CKM syndrome, among whom patients at stage 4 exhibit a 4-fold higher mortality risk compared with those at stage 0. Representing a very-high-risk population, they are in urgent need of targeted interventions.
Chronic inflammation constitutes the core pathological mechanism underlying CKM progression. Circulating inflammatory biomarkers currently lack sufficient specificity, while PET-CT is costly and poorly accessible, limiting its clinical utility. Studies have demonstrated that fat attenuation index (FAI), calculated by analyzing the radiodensity of pericoronary adipose tissue (PCAT) derived from coronary computed-tomographic angiography (CCTA), enables non-invasive quantification of coronary inflammation. In the setting of arterial inflammation, PCAT loses lipid content with an elevated water-to-lipid ratio, shifting FAI from the lipid-rich phase (approximately -190 HU) toward the water-rich phase (approximately -30 HU). As a novel surrogate inflammatory biomarker, PCAT holds promise as a new therapeutic target for cardiovascular diseases.
Beyond their glucose-lowering and diuretic effects, sodium-glucose cotransporter 2 inhibitors (SGLT2is) exert anti-inflammatory properties, including suppression of inflammatory-cytokine expression and mitigation of oxidative stress. They also reduce the thickness and volume of epicardial adipose tissue (EAT) and dampen its secretion of inflammatory cytokines, which may represent an important pathway mediating their cardiovascular benefits. Nevertheless, existing studies enroll relatively homogeneous populations and do not cover the high-risk stage-4 CKM cohort. Patients with stage-4 CKM have greater EAT burden, and EAT contributes to disease progression. Accordingly, leveraging photon-counting CT, this study aims to explore the modulatory effect of 6-month SGLT2i therapy on local coronary inflammation in stage-4 CKM patients, as well as the association between clinical benefits and alleviated coronary inflammation, so as to provide theoretical evidence for targeted anti-inflammatory therapy in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will undergo CCTA at 1 month after PCI. Those meeting all criteria will then be randomized 1:1 to the dapagliflozin group or standard care group using a dynamic block randomization method.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Experimental | Drug: DapagliflozinParticipants receive dapagliflozin 10 mg orally once daily in addition to guideline-directed medical therapy for 6 months. |
| Non-dapagliflozin group | No intervention | –Participants receive guideline-directed medical therapy alone without any SGLT2 inhibitor for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18 years, irrespective of gender;
- Meeting the diagnostic criteria for stage 4 CKM syndrome;
- Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;
- Signed informed consent form.
Key exclusion criteria (9 listed)
- Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;
- Severe hepatic dysfunction (Child-Pugh class C);
- History of recurrent urogenital tract infections;
- History of allergy or intolerance to SGLT2 inhibitors;
- Pregnant or lactating women;
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 |
|---|---|---|
| Dapagliflozin10 mg/d for 6 months | Drug | Dapagliflozin group |
Primary outcome
Changes in FAI from baseline to 6 months in patients assessed by CCTA
Time frame: From randomization to 6 months post-randomization
Change in FAI of major coronary arteries (left main [LM], right coronary artery [RCA], left anterior descending [LAD], and left circumflex [LCX]) from baseline to 6 months, expressed in Hounsfield Units (HU), assessed at the patient level.
6 secondary outcomes
Change in total plaque volume
Time frame: From randomization to 6 months post-randomization
Change in calcified plaque volume
Time frame: From baseline (at randomization) to 6 months post-randomization
Change in fibrous plaque volume
Time frame: From baseline (at randomization) to 6 months post-randomization
Change in fibrofatty plaque volume
Time frame: From baseline (at randomization) to 6 months post-randomization
Change in low-attenuation plaque volume
Time frame: From baseline (at randomization) to 6 months post-randomization
Change in coronary stenosis
Time frame: From baseline (at randomization) to 6 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
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 Dapagliflozin in people with ACS (Acute Coronary Syndrome) and SGLT2 Inhibitors, run by Shenyang Northern Hospital at 1 site in China.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FAI from baseline to 6 months in patients assessed by CCTA (time frame: From randomization to 6 months post-randomization). 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 30 Oct 2026.