Anti-thrombotic and Glucose Lowering Therapy in Diabetic Patients Undergoing PCI
- Conditions
- Type2 Diabetes MellitusCoronary Heart Disease
- Interventions
- Other: Exposure to Anti-thrombotic treatment agents and glucose lowering therapy
- Registration Number
- NCT04481997
- Lead Sponsor
- Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diabetic patients with CAD submitted to PCI Exposure to Anti-thrombotic treatment agents and glucose lowering therapy Individuals with type 2 Diabetes mellitus (previously diagnosed or diagnosed at index admission) submitted to PCI
- Primary Outcome Measures
Name Time Method Reasons for prolonging DAPT over 1 year 12 to 24 months follow-up 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (12)
Hospital Prof. Doutor Fernando Fonseca
🇵🇹Amadora, Lisbon, 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
Centro Hospitalar Lisboa Central - Hospital de Santa Marta
🇵🇹Lisboa, Lisbon, Portugal
Hospital Garcia de Orta
🇵🇹Almada, Setúbal, Portugal
Hospital de Braga, EPE
🇵🇹Braga, Portugal
Centro Hospitalar de Setúbal
🇵🇹Setúbal, Portugal
Centro Hospitalar Universitário do Algarve - Hospital de Faro
🇵🇹Faro, 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 Vila Nova de Gaia/Espinho, EPE
🇵🇹Vila Nova De Gaia, Porto, Portugal
Hospital do Espírito Santo de Évora, EPE
🇵🇹Évora, Portugal