NCT04481997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

June 26, 2020

Last Update Submit

August 25, 2025

Conditions

Type2 Diabetes MellitusCoronary Heart Disease

Keywords

PCI-Percutaneous Coronary InterventionDiabetes MellitusDual Antiplatelet TherapyAnti-diabetic drugs

Outcome Measures

Primary Outcomes (6)

  • Enumeration of the anti-thrombotic agents prescribed to patients

    Baseline to 24 months follow-up

  • Planned duration of dual anti-platelet treatment (DAPT) after the PCI.

    From index admission to 24 months follow-up

  • Adherence to anti-thrombotic regimen

    Classified qualitatively according to the assessment of the attending physician.

    6 to 24 months follow-up

  • Actual duration of DAPT (if different from the planned duration)

    6 to 24 months follow-up

  • Reasons for interrupting DAPT at a time different from the planned duration

    6 to 24 months follow-up

  • Reasons for prolonging DAPT over 1 year

    12 to 24 months follow-up

Secondary Outcomes (13)

  • Major Adverse Coronary Events (MACE)

    6 to 24 months follow-up

  • Death rate from any cause

    6 to 24 months follow-up

  • Rate of cardiovascular death

    6 to 24 months follow-up

  • Rate of new spontaneous acute myocardial infarction

    6 to 24 months follow-up

  • Rate of hospital admissions for acute coronary infarction

    6 to 24 months follow-up

  • +8 more secondary outcomes

Study Arms (1)

Diabetic patients with CAD submitted to PCI

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

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

Interventions

Exposure to Anti-thrombotic treatment agents and glucose lowering therapyOTHER

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Diabetic patients with CAD submitted to PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 Type 2 Diabetes mellitus consecutive patients submitted to PCI in 12 interventional Cardiology Portuguese centers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital de Braga, EPE

Braga, Braga District, 4710-243, Portugal

Location

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

Coimbra, Coimbra District, 3000-075, Portugal

Location

Centro Hospitalar Universitário do Algarve - Hospital de Faro

Faro, Faro District, 8000-386, Portugal

Location

Hospital Prof. Doutor Fernando Fonseca

Amadora, Lisbon District, 2720-276, Portugal

Location

Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz

Carnaxide, Lisbon District, 2790-134, Portugal

Location

Centro Hospitalar Lisboa Central - Hospital de Santa Marta

Lisbon, Lisbon District, 1159-064, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

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

Porto, Porto District, 4099-001, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Hospital Garcia de Orta

Almada, Setúbal District, 2805-267, Portugal

Location

Centro Hospitalar de Setúbal

Setúbal, Setúbal District, 2910-549, Portugal

Location

Hospital do Espírito Santo de Évora, EPE

Evora, Évora District, 7000-811, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 40738464DERIVED

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sérgio B Baptista, PhD

    Cardiovascular Centre of the University of Lisbon (CCUL)

    PRINCIPAL INVESTIGATOR

  • Luís Raposo, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 22, 2020

Study Start

January 11, 2021

Primary Completion

November 4, 2023

Study Completion

January 30, 2024

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

PT(12)