Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting (DAPT-FOR-REAL)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05559918

AUMC25485

Details and patient eligibility

About

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.

Enrollment: 1,462 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,462 participants in 2 patient groups

Preloading with clopidogrel

In-hospital loading with clopidogrel