NCT05559918
Recruiting
Not Applicable
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 sites in 1 country1,462 target enrollmentOctober 1, 2022
ConditionsCoronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 1462
- Locations
- 2
- Primary Endpoint
- Net adverse clinical events (NACE)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ronak Delewi
Principal Investigator Dr. R Delewi
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
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
Outcomes
Primary Outcomes
Net adverse clinical events (NACE)
Time Frame: 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 Outcomes
- Bleeding (classified as BARC type 2, -3 and -5 bleeding)(In-hospital, at 30 days)
- Stroke(In-hospital, at 30 days)
- Patient oriented clinical events (POCE)(In-hospital, at 30 days)
- Myocardial infarction(In-hospital, at 30 days)
- Stent thrombosis (definite/probable)(In-hospital, at 30 days)
- All-cause mortality(In-hospital, at 30 days)
- Repeat revascularisation(In-hospital, at 30 days)
Study Sites (2)
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