Clinical trial NCT04481997: Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes Mellitus
Coronary Heart Disease
Keywords: PCI-Percutaneous Coronary Intervention
Diabetes Mellitus
Dual Antiplatelet Therapy
Anti-diabetic drugs
Lead sponsor: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Sponsor class: OTHER
Collaborators: name: Cardiovascular Centre of the University of Lisbon (CCUL)
name: AstraZeneca
First posted: 2020-07-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 Type 2 Diabetes mellitus consecutive patients submitted to PCI in 12 interventional Cardiology Portuguese centers

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.

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

Primary outcomes:
measure: Enumeration of the anti-thrombotic agents prescribed to patients
timeFrame: Baseline to 24 months follow-up
measure: Planned duration of dual anti-platelet treatment (DAPT) after the PCI.
timeFrame: From index admission to 24 months follow-up
measure: Adherence to anti-thrombotic regimen
timeFrame: 6 to 24 months follow-up
measure: Actual duration of DAPT (if different from the planned duration)
timeFrame: 6 to 24 months follow-up
measure: Reasons for interrupting DAPT at a time different from the planned duration
timeFrame: 6 to 24 months follow-up
measure: Reasons for prolonging DAPT over 1 year
timeFrame: 12 to 24 months follow-up
Secondary outcomes:
measure: Major Adverse Coronary Events (MACE)
timeFrame: 6 to 24 months follow-up
measure: Death rate from any cause
timeFrame: 6 to 24 months follow-up
measure: Rate of cardiovascular death
timeFrame: 6 to 24 months follow-up
measure: Rate of new spontaneous acute myocardial infarction
timeFrame: 6 to 24 months follow-up
measure: Rate of hospital admissions for acute coronary infarction
timeFrame: 6 to 24 months follow-up
measure: Rate of unplanned coronary revascularization
timeFrame: 6 to 24 months follow-up
measure: Rate of stroke/transient ischemic attack
timeFrame: 6 to 24 months follow-up
measure: Death rate from heart failure
timeFrame: 6 to 24 months follow-up
measure: Rate of hospital admission due to heart failure
timeFrame: 6 to 24 months follow-up
measure: Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale
timeFrame: 6 to 24 months follow-up
measure: Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale
timeFrame: 6 to 24 months follow-up
measure: Percentage of patients treated with different glucose-lowering drugs.
timeFrame: Before index admission to 24 months follow-up.
measure: Diabetes control (HbA1c values)
timeFrame: At baseline to 24 months follow-up
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca
state: Lisbon
city: Carnaxide
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
state: Lisbon
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Central - Hospital de Santa Marta
state: Lisbon
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
state: Lisbon
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
state: Porto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
state: Setúbal
city: Braga
country: Portugal
facility: Hospital de Braga, EPE
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra
city: Faro
country: Portugal
facility: Centro Hospitalar Universitário do Algarve - Hospital de Faro
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
city: Setúbal
country: Portugal
facility: Centro Hospitalar de Setúbal
city: Évora
country: Portugal
facility: Hospital do Espírito Santo de Évora, EPE
Study officials:
affiliation: Cardiovascular Centre of the University of Lisbon (CCUL)
name: Sérgio B Baptista, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Santa Cruz, CHLO, EPE, Lisbon, Portugal
name: Luís Raposo, MD
role: PRINCIPAL_INVESTIGATOR
References: