Health TrialsbyHealthPanel

CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF

ConditionsACS (Acute Coronary Syndrome)SGLT2 Inhibitors
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Northern Hospital

About this trial

The goal of this clinical trial is to learn if dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce coronary artery inflammation in people with acute coronary syndrome (ACS) who do not have diabetes or heart failure.

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 randomization * Have blood tests at the time of PCI, at randomization, and at 6 months after randomization * Receive follow-up phone calls at 3 and 6 months after randomization

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina)

Undergoing percutaneous coronary intervention (PCI)

Presence of multivessel coronary artery disease with at least one non-culprit vessel not undergoing revascularization (for CCTA follow-up assessment)

Disqualifiers

Prior or current diagnosis of diabetes mellitus

Prior or current diagnosis of chronic heart failure

Treatment with any SGLT2 inhibitor within 4 weeks prior to enrollment

Severe hepatic impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    10 mg/d for 6 months

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin groupExperimental treatment 1 intervention
Group B: Non-dapagliflozin groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From randomization to 6 months post-randomization

Secondary outcomes

1

Change in total plaque volume

Absolute change in total coronary plaque volume (mm³)

Time frame
From randomization to 6 months post-randomization
2

Change in calcified plaque volume

Absolute change in calcified plaque volume (mm³)

Time frame
From baseline (at randomization) to 6 months post-randomization
3

Change in fibrous plaque volume

Absolute change in fibrous plaque volume (mm³)

Time frame
From baseline (at randomization) to 6 months post-randomization
4

Change in fibrofatty plaque volume

Absolute change in fibrofatty plaque volume (mm³)

Time frame
From baseline (at randomization) to 6 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Northern Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: