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

August 25, 2025 updated by: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

Anti-thrombotic and Glucose loweRing THerapy in diabEtics With CAD Undergoing PCI: a Prospective Multicenter observatIonal Study on Their Use and Implications for Clinical Outcomes - The ARTHEMIS Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Braga District
      • Braga, Braga District, Portugal, 4710-243
        • Hospital de Braga, EPE
    • Coimbra District
      • Coimbra, Coimbra District, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra
    • Faro District
      • Faro, Faro District, Portugal, 8000-386
        • Centro Hospitalar Universitário do Algarve - Hospital de Faro
    • Lisbon District
      • Amadora, Lisbon District, Portugal, 2720-276
        • Hospital Prof. Doutor Fernando Fonseca
      • Carnaxide, Lisbon District, Portugal, 2790-134
        • Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
      • Lisbon, Lisbon District, Portugal, 1159-064
        • Centro Hospitalar Lisboa Central - Hospital de Santa Marta
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
    • Porto District
      • Porto, Porto District, Portugal, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Hospital Garcia de Orta
      • Setúbal, Setúbal District, Portugal, 2910-549
        • Centro Hospitalar de Setubal
    • Évora District
      • Evora, Évora District, Portugal, 7000-811
        • Hospital do Espírito Santo de Évora, EPE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enumeration of the anti-thrombotic agents prescribed to patients
Time Frame: Baseline to 24 months follow-up
Baseline to 24 months follow-up
Planned duration of dual anti-platelet treatment (DAPT) after the PCI.
Time Frame: From index admission to 24 months follow-up
From index admission to 24 months follow-up
Adherence to anti-thrombotic regimen
Time Frame: 6 to 24 months follow-up
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)
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Reasons for interrupting DAPT at a time different from the planned duration
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Reasons for prolonging DAPT over 1 year
Time Frame: 12 to 24 months follow-up
12 to 24 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Adverse Coronary Events (MACE)
Time Frame: 6 to 24 months follow-up
Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).
6 to 24 months follow-up
Death rate from any cause
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of cardiovascular death
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of new spontaneous acute myocardial infarction
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of hospital admissions for acute coronary infarction
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of unplanned coronary revascularization
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of stroke/transient ischemic attack
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Death rate from heart failure
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of hospital admission due to heart failure
Time Frame: 6 to 24 months follow-up
6 to 24 months follow-up
Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale
Time Frame: 6 to 24 months follow-up
The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will only be collected the events corresponding to type 3-5 of BARC scale.
6 to 24 months follow-up
Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale
Time Frame: 6 to 24 months follow-up
The BARC (Bleeding Academic Research Consortium) scale will be used. The minimum and maximum scores of the scale are, respectively, type 0 (no bleeding) and type 5 (fatal). There will be collected the events corresponding to type 1-5 of BARC scale.
6 to 24 months follow-up
Percentage of patients treated with different glucose-lowering drugs.
Time Frame: Before index admission to 24 months follow-up.
Before index admission to 24 months follow-up.
Diabetes control (HbA1c values)
Time Frame: At baseline to 24 months follow-up
At baseline to 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca
Cardiovascular Centre of Universidade de Lisboa (CCUL)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CET.NIS2020.01
  • ESR-19-20188 (Other Grant/Funding Number: AstraZeneca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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