Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI (ARTHEMIS)

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

Status: Unknown

Conditions: Coronary Heart Disease; Type2 Diabetes Mellitus

Treatments: Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04481997

ESR-19-20188 (Other Grant/Funding Number)

CET.NIS2020.01

Details and patient eligibility

About

Diabetes mellitus (DM) is one of the main risk factors for ischemic events in patients with coronary artery disease (CAD) and diabetes is a factor in several post-PCI (Percutaneous Coronary Intervention) risk scores. However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. This study aims to describe the anti-thrombotic regimens, clinical outcomes and current diabetes medical treatment in an unselected consecutive population of patients with DM undergoing PCI.

Full description

Diabetes is one of the main risk factors for ischemic events in patients with coronary artery disease and diabetes is a factor in several post-PCI risk scores (including the commonly used DAPT score). However, until recently, there were almost no studies performed specifically in the diabetic population of patients undergoing PCI. At large, results from randomized trials assessing the duration of DAPT have produced conflicting results and there is uncertainty about the best anti-thrombotic strategy in patients with diabetes. Further assessment of the patterns of use and their clinical effects, including those related to prolonged DAPT is needed, in diabetic patients, especially in less selected "real world" populations.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCI with stent implantation, performed in at least one major coronary artery in the context of stable coronary artery disease or acute coronary syndrome
• Type 2 Diabetes mellitus (previously diagnosed or diagnosed at the index admission)
• Informed consent signed
• Patient not simultaneously participating in any interventional study

Exclusion criteria

• Patients with Type 1 Diabetes mellitus
• Patients whose survival is expected to be lower than 1 year at hospital discharge
• Patients not whiling to participate

Trial design

1,000 participants in 1 patient group

Diabetic patients with CAD submitted to PCI

Description:

Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI

Treatment:

Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy