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Completed

NCT Number: NCT04481997

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

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.

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Key information

Conditions

Type2 Diabetes Mellitus Cardiovascular Diseases Coronary Disease Coronary Heart Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Braga, EPE, Braga, Braga District, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Other

Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

Primary outcomes

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

    Time frame: Baseline to 24 months follow-up

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

    Time frame: From index admission to 24 months follow-up

  3. Adherence to anti-thrombotic regimen

    Time frame: 6 to 24 months follow-up

    Classified qualitatively according to the assessment of the attending physician.

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

    Time frame: 6 to 24 months follow-up

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

    Time frame: 6 to 24 months follow-up

  6. Reasons for prolonging DAPT over 1 year

    Time frame: 12 to 24 months follow-up

Secondary outcomes

  1. 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).

  2. Death rate from any cause

    Time frame: 6 to 24 months follow-up

  3. Rate of cardiovascular death

    Time frame: 6 to 24 months follow-up

  4. Rate of new spontaneous acute myocardial infarction

    Time frame: 6 to 24 months follow-up

  5. Rate of hospital admissions for acute coronary infarction

    Time frame: 6 to 24 months follow-up

  6. Rate of unplanned coronary revascularization

    Time frame: 6 to 24 months follow-up

  7. Rate of stroke/transient ischemic attack

    Time frame: 6 to 24 months follow-up

  8. Death rate from heart failure

    Time frame: 6 to 24 months follow-up

  9. Rate of hospital admission due to heart failure

    Time frame: 6 to 24 months follow-up

  10. 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.

  11. 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.

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

    Time frame: Before index admission to 24 months follow-up.

  13. Diabetes control (HbA1c values)

    Time frame: At baseline to 24 months follow-up

Sponsors and collaborators

Lead sponsor

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

Other

Collaborators

  • AstraZeneca
  • Cardiovascular Centre of Universidade de Lisboa (CCUL)

Registry information

Official study 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

Acronym: ARTHEMIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 22, 2020
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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