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

Sponsor

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04481997

Collaborator

Cardiovascular Centre of the University of Lisbon (CCUL) (Other), AstraZeneca (Industry)

1,000

Enrollment

Locations

34.6

Anticipated Duration (Months)

83.3

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus Coronary Heart Disease	Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 11, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Enumeration of the anti-thrombotic agents prescribed to patients [Baseline to 24 months follow-up]
Planned duration of dual anti-platelet treatment (DAPT) after the PCI. [From index admission to 24 months follow-up]
Adherence to anti-thrombotic regimen [6 to 24 months follow-up]
Classified qualitatively according to the assessment of the attending physician.
Actual duration of DAPT (if different from the planned duration) [6 to 24 months follow-up]
Reasons for interrupting DAPT at a time different from the planned duration [6 to 24 months follow-up]
Reasons for prolonging DAPT over 1 year [12 to 24 months follow-up]

Secondary Outcome Measures

Major Adverse Coronary Events (MACE) [6 to 24 months follow-up]
Major Adverse Coronary Events (MACE) (death from any cause, new spontaneous acute myocardial infarction, stroke).
Death rate from any cause [6 to 24 months follow-up]
Rate of cardiovascular death [6 to 24 months follow-up]
Rate of new spontaneous acute myocardial infarction [6 to 24 months follow-up]
Rate of hospital admissions for acute coronary infarction [6 to 24 months follow-up]
Rate of unplanned coronary revascularization [6 to 24 months follow-up]
Rate of stroke/transient ischemic attack [6 to 24 months follow-up]
Death rate from heart failure [6 to 24 months follow-up]
Rate of hospital admission due to heart failure [6 to 24 months follow-up]
Rate of bleeding events of type 3-5 of BARC (Bleeding Academic Research Consortium) scale [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.
Rate of bleeding events of type 1-5 of BARC (Bleeding Academic Research Consortium) scale [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.
Percentage of patients treated with different glucose-lowering drugs. [Before index admission to 24 months follow-up.]
Diabetes control (HbA1c values) [At baseline to 24 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Prof. Doutor Fernando Fonseca	Amadora	Lisbon	Portugal	2720-276
2	Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz	Carnaxide	Lisbon	Portugal	2790-134
3	Centro Hospitalar Lisboa Central - Hospital de Santa Marta	Lisboa	Lisbon	Portugal	1159-064
4	Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria	Lisboa	Lisbon	Portugal	1649-035
5	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE	Vila Nova De Gaia	Porto	Portugal	4434-502
6	Hospital Garcia de Orta	Almada	Setúbal	Portugal	2805-267
7	Hospital de Braga, EPE	Braga		Portugal	4710-243
8	Centro Hospitalar e Universitário de Coimbra - Hospital Geral & Hospital Universitário de Coimbra	Coimbra		Portugal	3000-075
9	Centro Hospitalar Universitário do Algarve - Hospital de Faro	Faro		Portugal	8000-386
10	Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António	Porto		Portugal	4099-001
11	Centro Hospitalar de Setúbal	Setúbal		Portugal	2910-549
12	Hospital do Espírito Santo de Évora, EPE	Évora		Portugal	7000-811

Sponsors and Collaborators

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

Investigators

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