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

Coronary Heart Disease Clinical Trial

— ARTHEMIS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04481997
• Other study ID #: CET.NIS2020.01
• Secondary ID: ESR-19-20188
• Status: Active, not recruiting
• Start date: January 11, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2021
• Source: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia
• Type2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Portugal	Hospital Garcia de Orta	Almada	Setúbal
Portugal	Hospital Prof. Doutor Fernando Fonseca	Amadora	Lisbon
Portugal	Hospital de Braga, EPE	Braga
Portugal	Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz	Carnaxide	Lisbon
Portugal	Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra	Coimbra
Portugal	Hospital do Espírito Santo de Évora, EPE	Évora
Portugal	Centro Hospitalar Universitário do Algarve - Hospital de Faro	Faro
Portugal	Centro Hospitalar Lisboa Central - Hospital de Santa Marta	Lisboa	Lisbon
Portugal	Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria	Lisboa	Lisbon
Portugal	Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António	Porto
Portugal	Centro Hospitalar de Setúbal	Setúbal
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE	Vila Nova De Gaia	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA	AstraZeneca, Cardiovascular Centre of the University of Lisbon (CCUL)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enumeration of the anti-thrombotic agents prescribed to patients		Baseline to 24 months follow-up
Primary	Planned duration of dual anti-platelet treatment (DAPT) after the PCI.		From index admission to 24 months follow-up
Primary	Adherence to anti-thrombotic regimen	Classified qualitatively according to the assessment of the attending physician.	6 to 24 months follow-up
Primary	Actual duration of DAPT (if different from the planned duration)		6 to 24 months follow-up
Primary	Reasons for interrupting DAPT at a time different from the planned duration		6 to 24 months follow-up
Primary	Reasons for prolonging DAPT over 1 year		12 to 24 months follow-up
Secondary	Major Adverse Coronary Events (MACE)	Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).	6 to 24 months follow-up
Secondary	Death rate from any cause		6 to 24 months follow-up
Secondary	Rate of cardiovascular death		6 to 24 months follow-up
Secondary	Rate of new spontaneous acute myocardial infarction		6 to 24 months follow-up
Secondary	Rate of hospital admissions for acute coronary infarction		6 to 24 months follow-up
Secondary	Rate of unplanned coronary revascularization		6 to 24 months follow-up
Secondary	Rate of stroke/transient ischemic attack		6 to 24 months follow-up
Secondary	Death rate from heart failure		6 to 24 months follow-up
Secondary	Rate of hospital admission due to heart failure		6 to 24 months follow-up
Secondary	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.	6 to 24 months follow-up
Secondary	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.	6 to 24 months follow-up
Secondary	Percentage of patients treated with different glucose-lowering drugs.		Before index admission to 24 months follow-up.
Secondary	Diabetes control (HbA1c values)		At baseline to 24 months follow-up