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

NCT ID: NCT04481997

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2024-01-30

Brief Summary

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.

Detailed 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.

Conditions

Type2 Diabetes Mellitus; Coronary Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic patients with CAD submitted to PCI

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

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Intervention Type: OTHER

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Interventions

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Cardiovascular Centre of Universidade de Lisboa (CCUL)

UNKNOWN

Sponsor Role: collaborator

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sérgio B Baptista, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Centre of the University of Lisbon (CCUL)

Luís Raposo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal

Locations

Hospital de Braga, EPE

Braga, Braga District, Portugal

Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra

Coimbra, Coimbra District, Portugal

Centro Hospitalar Universitário do Algarve - Hospital de Faro

Faro, Faro District, Portugal

Hospital Prof. Doutor Fernando Fonseca

Amadora, Lisbon District, Portugal

Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz

Carnaxide, Lisbon District, Portugal

Centro Hospitalar Lisboa Central - Hospital de Santa Marta

Lisbon, Lisbon District, Portugal

Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

Lisbon, Lisbon District, Portugal

Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

Porto, Porto District, Portugal

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Vila Nova de Gaia, Porto District, Portugal

Hospital Garcia de Orta

Almada, Setúbal District, Portugal

Centro Hospitalar de Setúbal

Setúbal, Setúbal District, Portugal

Hospital do Espírito Santo de Évora, EPE

Evora, Évora District, Portugal

Countries

Portugal

References

Bravo Baptista S, Pires de Morais G, Almeida Morais L, Costa J, Vinhas H, Campos G, Carrilho Ferreira P, Vale N, Seixo F, Santos M, Martins C, Rodrigues Bras D, Alexandre A, Raposo L. Anti-thrombotic and glucose lowering therapy in diabetic patients with coronary artery disease undergoing PCI with stent implantation: A prospective multicenter observational study on prescription patterns and clinical outcomes. Baseline inclusion data of the ARTHEMIS registry. Rev Port Cardiol. 2025 Sep;44(9):537-546. doi: 10.1016/j.repc.2025.03.006. Epub 2025 Jul 28. English, Portuguese.

Reference Type: DERIVED

PMID: 40738464 (View on PubMed)

Other Identifiers

ESR-19-20188

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CET.NIS2020.01

Identifier Type: -

Identifier Source: org_study_id