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Type2 Diabetes MellitusARTHEMISNCT04481997

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

An observational study of Type2 Diabetes Mellitus and Coronary Heart Disease, run by Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA at 12 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
How many people
1,000 participants
Where
12 sitesPortugal
Study dates
11 Jan 2021to 30 Jan 2024
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

Portugal12 sites

  • Hospital Garcia de Orta

    Almada, Setúbal District, 2805-267

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, Lisbon District, 2720-276

  • Hospital de Braga, EPE

    Braga, Braga District, 4710-243

  • Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz

    Carnaxide, Lisbon District, 2790-134

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

    Coimbra, Coimbra District, 3000-075

  • Hospital do Espírito Santo de Évora, EPE

    Evora, Évora District, 7000-811

  • Centro Hospitalar Universitário do Algarve - Hospital de Faro

    Faro, Faro District, 8000-386

  • Centro Hospitalar Lisboa Central - Hospital de Santa Marta

    Lisbon, Lisbon District, 1159-064

  • Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

    Lisbon, Lisbon District, 1649-035

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

    Porto, Porto District, 4099-001

  • Centro Hospitalar de Setúbal

    Setúbal, Setúbal District, 2910-549

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
Keywords
PCI-Percutaneous Coronary Intervention, Diabetes Mellitus, Dual Antiplatelet Therapy, Anti-diabetic drugs
Medical subject headings
Coronary Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure to Anti-thrombotic treatment agents and glucose lowering therapyOther

    Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Study groups in NCT04481997
Study groupRoleWhat they receive
Diabetic patients with CAD submitted to PCIIndividuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI
Receives: Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enumeration of the anti-thrombotic agents prescribed to patients

    Measured: Baseline to 24 months follow-up

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

    Measured: From index admission to 24 months follow-up

  3. Adherence to anti-thrombotic regimen

    Classified qualitatively according to the assessment of the attending physician.

    Measured: 6 to 24 months follow-up

  4. Actual duration of DAPT (if different from the planned duration)

    Measured: 6 to 24 months follow-up

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

    Measured: 6 to 24 months follow-up

  6. Reasons for prolonging DAPT over 1 year

    Measured: 12 to 24 months follow-up

Secondary outcomes (13)

  1. Major Adverse Coronary Events (MACE)

    Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).

    Measured: 6 to 24 months follow-up

  2. Death rate from any cause

    Measured: 6 to 24 months follow-up

  3. Rate of cardiovascular death

    Measured: 6 to 24 months follow-up

  4. Rate of new spontaneous acute myocardial infarction

    Measured: 6 to 24 months follow-up

  5. Rate of hospital admissions for acute coronary infarction

    Measured: 6 to 24 months follow-up

  6. Rate of unplanned coronary revascularization

    Measured: 6 to 24 months follow-up

  7. Rate of stroke/transient ischemic attack

    Measured: 6 to 24 months follow-up

  8. Death rate from heart failure

    Measured: 6 to 24 months follow-up

  9. Rate of hospital admission due to heart failure

    Measured: 6 to 24 months follow-up

  10. Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale

    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.

    Measured: 6 to 24 months follow-up

  11. Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale

    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.

    Measured: 6 to 24 months follow-up

  12. Percentage of patients treated with different glucose-lowering drugs.

    Measured: Before index admission to 24 months follow-up.

  13. Diabetes control (HbA1c values)

    Measured: At baseline to 24 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start11 Jan 2021
  3. Primary completion4 Nov 2023
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04481997
Sponsor's protocol ID
CET.NIS2020.01
Other IDs
ESR-19-20188
Acronym
ARTHEMIS
Status last verified
Aug 2025
First submitted
26 Jun 2020
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40738464

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes Mellitus and Coronary Heart Disease, run by Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA at 12 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enumeration of the anti-thrombotic agents prescribed to patients (time frame: Baseline to 24 months follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04481997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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