Coronary Artery Disease
Conditions
Keywords
Pretreatment, Diagnostic angiography, ad-hoc PCI
Brief summary
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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women aged at least 18 years * Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease
Exclusion criteria
* Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers) * Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke) * Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor) * Patients using VKA (e.g. acenocoumarol, fenprocoumon) * Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical events (NACE) | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient oriented clinical events (POCE) | In-hospital, at 30 days | The incidence rate of POCE (the composite of clinical events all-cause death, stroke, myocardial infarction, and repeat revascularization) will be compared between groups |
| All-cause mortality | In-hospital, at 30 days | The incidence rate of all-cause mortality will be compared between groups |
| Myocardial infarction | In-hospital, at 30 days | The incidence rate of myocardial infarction will be compared between groups |
| Bleeding (classified as BARC type 2, -3 and -5 bleeding) | In-hospital, at 30 days | The incidence rate of bleeding (classified as BARC type 2, -3 and -5 bleeding) will be compared between groups |
| Stroke | In-hospital, at 30 days | The incidence rate of stroke will be compared between groups |
| Repeat revascularisation | In-hospital, at 30 days | The incidence rate of repeat revascularisation will be compared between groups |
| Stent thrombosis (definite/probable) | In-hospital, at 30 days | The incidence rate of stent thrombosis (definite and probable) will be compared between groups |
Countries
Netherlands
Contacts
Primary ContactRonak Delewi, MD, PhD
Outcome results
None listed