Coronary Artery DiseaseNCT05333159
The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
An observational study of Coronary Artery Disease and Diabete Mellitus, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabete Mellitus
- What is being tested?
- SGLT2 inhibitor
- How many people
- 1,424 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Dec 2024
- Phase
- Observational
- 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
Study population: Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
Who may be able to join
- Age ≥18 years
- Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
- Patients were provided informed consent before the procedure.
Who cannot join
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of one or more severe hypoglycemic episode within 6 months before screening
- Ongoing, inadequately controlled thyroid disorder.
- History of hepatitis B surface antigen or hepatitis C antibody positive
- Any history of or planned bariatric surgery.
- Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality
xiaofan Wu, MD, 6445-6587, drwuxf@163.com
About this study
Official title: Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study
The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.
Read the detailed description
This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.
- Conditions
- Coronary Artery Disease, Diabete Mellitus
- Being tested
- SGLT2 inhibitor
- Keywords
- coronary artery disease, diabetes mellitus, percutaneous coronary intervention, SGLT-2 inhibitor, insulin resistance, platelet reactivity
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called dapagliflozin, canagliflozin, empagliflozin
dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs . Receives: Drug: SGLT2 inhibitor | |
| Control | Subjects will be only treated with conventional hypoglycemic drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events (MACCEs)
MACCE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal myocardial stroke and unplanned coronary revascularization. Event rates are adjudicated by an endpoint committee based on the time to the first occurrence of MACCEs.
Measured: 12 months
Secondary outcomes (5)
Changes of insulin resistance index
Changes of insulin resistance index at baseline prior to drug administration and at 3 months after the index PCI.
Measured: 3 months
Changes of platelet reactivity
Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.
Measured: 3 months
Changes of fasting plasma glucose (FPG) level
Changes of FPG level at baseline prior to drug administration and at 3 months after the index PCI.
Measured: 12 months
Changes of glycated hemoglobin (HbA1c)
Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.
Measured: 12 months
Changes of plasma lipid parameters
Changes of plasma lipid parameters including triglycerides, high-density lipoprotein cholesterol and low density lipoprotein cholesterol and total cholesterol at baseline prior to drug administration and at 12 months after the index PCI.
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 posted18 Apr 2022
- Study start1 Sep 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofan Wu, Beijing Anzhen Hospital
- Investigators
- xiaofan Wu, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333159
- Sponsor's protocol ID
- KS2022016
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05333159
- Acronym / sponsor ID
- KS2022016
- Conditions
- Coronary Artery Disease, Diabete Mellitus
- Keywords
- coronary artery disease, diabetes mellitus, percutaneous coronary intervention, SGLT-2 inhibitor, insulin resistance, platelet reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,424 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 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.
The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.
Detailed description
This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: SGLT2 inhibitorSubjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs . |
| Control | – | –Subjects will be only treated with conventional hypoglycemic drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
- Patients were provided informed consent before the procedure.
Key exclusion criteria (6 listed)
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- History of one or more severe hypoglycemic episode within 6 months before screening
- Ongoing, inadequately controlled thyroid disorder.
- History of hepatitis B surface antigen or hepatitis C antibody positive
- Any history of or planned bariatric surgery.
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 |
|---|---|---|
| SGLT2 inhibitorAlso: dapagliflozin, canagliflozin, empagliflozindapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose | Drug | Experimental |
Primary outcome
Major adverse cardiovascular and cerebrovascular events (MACCEs)
Time frame: 12 months
MACCE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal myocardial stroke and unplanned coronary revascularization. Event rates are adjudicated by an endpoint committee based on the time to the first occurrence of MACCEs.
5 secondary outcomes
Changes of insulin resistance index
Time frame: 3 months
Changes of platelet reactivity
Time frame: 3 months
Changes of fasting plasma glucose (FPG) level
Time frame: 12 months
Changes of glycated hemoglobin (HbA1c)
Time frame: 12 months
Changes of plasma lipid parameters
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 18 Apr 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.
xiaofan Wu, MD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Diabete Mellitus, run by Beijing Anzhen 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 3 inclusion and 6 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 18 Apr 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 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.
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 xiaofan Wu, MD (6445-6587, drwuxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (MACCEs) (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 18 Apr 2022.