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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05559918
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1462

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Stent thrombosis (definite/probable)	In-hospital, at 30 days	The incidence rate of stent thrombosis (definite and probable) will be compared between groups
Stroke	In-hospital, at 30 days	The incidence rate of stroke will be compared between groups
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
Myocardial infarction	In-hospital, at 30 days	The incidence rate of myocardial infarction 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
Repeat revascularisation	In-hospital, at 30 days	The incidence rate of repeat revascularisation will be compared between groups

Trial Locations

Locations (2)

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands