Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting

Study Overview
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Brief Summary
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To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.

Official Title
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Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women aged at least 18 years Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease Exclusion Criteria: Patients known to be poor CYP2C19 metabolizers Patients using pharmacological CYP2C19 inhibitors and inducers Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding) Inability to give informed consent (e.g., language barrier) Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preloading with clopidogrel<br> | |
| In-hospital loading with clopidogrel<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical events (NACE) | The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding (classified as BARC type 2, -3 and -5 bleeding) | The incidence rate of bleeding (classified as BARC type 2, -3 and -5 bleeding) will be compared between groups | In-hospital, at 30 days | 
| Patient oriented clinical events (POCE) | The incidence rate of POCE (the composite of clinical events all-cause death, stroke, myocardial infarction, and repeat revascularization) will be compared between groups | In-hospital, at 30 days | 
| All-cause mortality | The incidence rate of all-cause mortality will be compared between groups | In-hospital, at 30 days | 
| Myocardial infarction | The incidence rate of myocardial infarction will be compared between groups | In-hospital, at 30 days | 
| Stent thrombosis (definite/probable) | The incidence rate of stent thrombosis (definite and probable) will be compared between groups | In-hospital, at 30 days | 
| Stroke | The incidence rate of stroke will be compared between groups | In-hospital, at 30 days | 
| Repeat revascularisation | The incidence rate of repeat revascularisation will be compared between groups | In-hospital, at 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pretreatment, Diagnostic angiography, ad-hoc PCI