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

Coronary Artery Disease Clinical Trial

— DAPT-FOR-REAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559918
• Other study ID #: AUMC25485
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Ronak Delewi, MD, PhD
• Phone: +31(0)20 566 9111
• Email: r.delewi[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1462
• Est. completion date: December 31, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Netherlands	Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC	Amsterdam	Noord-Holland
Netherlands	Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	All-cause mortality	The incidence rate of all-cause mortality will be compared between groups	In-hospital, at 30 days
Secondary	Myocardial infarction	The incidence rate of myocardial infarction will be compared between groups	In-hospital, at 30 days
Secondary	Stent thrombosis (definite/probable)	The incidence rate of stent thrombosis (definite and probable) will be compared between groups	In-hospital, at 30 days
Secondary	Stroke	The incidence rate of stroke will be compared between groups	In-hospital, at 30 days
Secondary	Repeat revascularisation	The incidence rate of repeat revascularisation will be compared between groups	In-hospital, at 30 days