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To study the protective effect of dapagliflozin on perioperative myocardial injury/myocardial infarction in patients with chronic coronary syndrome complicated with diabetes mellitus undergoing elective PCI

To study the protective effect of dapagliflozin on perioperative myocardial injury/myocardial infarction in patients with chronic coronary syndrome complicated with diabetes mellitus undergoing elective PCI

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075232
Enrollment
Unknown
Registered
2023-08-30
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome

Interventions

Dapagliflozin was administered preoperatively:NA
Individuals who have not taken any type of SGLT2i before surgery:NA

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: ? Age = 18 years old, male or female; ? CCS patients with T2DM; ? Patients undergoing elective PCI (including coronary stent implantation and coronary balloon dilation); ? Dapagliflozin started at least 1 week (= 7 days) before PCI (study group) or no SGLT2i of any type at least 1 week (= 7 days) before PCI (control group); ? Normal or mildly impaired liver function (alanine aminotransferase = 1.5 times the upper limit of normal); ? Normal renal function or mild-moderate impairment (glomerular filtration rate = 45mL/min/1.73m²); ? Consent to sign informed consent and be able to cooperate with relevant tests, examinations and follow-up.

Exclusion criteria

Exclusion criteria: ? Patients did not undergo PCI for various reasons after CAG. ? Drug allergy and ketoacidosis occurred after dapagliflozin administration before PCI; ? There are non-coronary artery diseases that seriously affect cardiac function, such as moderate-severe valvular heart disease, artificial heart valve replacement, congenital heart disease, and other heart diseases. ? Coronary artery bypass grafting; ? New York Heart Association functional class III-IV; ? Serious diseases affecting life expectancy, such as malignant tumors, organ failure caused by various reasons, severe immune system diseases, hemodynamic instability, severe anemia, severe infection, etc. ? Administration of drugs with definite cardiotoxicity, such as anthracyclines; ? Other conditions considered by the researcher to be inappropriate for participation.

Design outcomes

Primary

MeasureTime frame
Periprocedural Myocardial Injury;4a myocardial infarction;—

Countries

China

Contacts

Public ContactDeping LIU

Beijing Hospital; National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences

lliudeping@263.net+86 136 7139 1504

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026