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

NCT05559918 | Recruiting

• 1 other identifier: AUMC25485
• Study Type: observational
• Target: 1,462
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

Pretreatment; Diagnostic angiography; ad-hoc PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Bleeding (classified as BARC type 2, -3 and -5 bleeding)

  In-hospital, at 30 days

• Patient oriented clinical events (POCE)

  In-hospital, at 30 days

• All-cause mortality

  In-hospital, at 30 days

• Myocardial infarction

  In-hospital, at 30 days

• Stent thrombosis (definite/probable)

  In-hospital, at 30 days

Study Arms (2)

Preloading with clopidogrel

In-hospital loading with clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.

You may qualify if:

• Adult men and women aged at least 18 years
• Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (2)

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC

Amsterdam, North Holland, Netherlands

RECRUITING

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC

Amsterdam, North Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ronak Delewi, MD, PhD

  Amsterdam University Medical Center, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronak Delewi, MD, PhD

CONTACT

+31(0)20 566 9111; r.delewi@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. R Delewi

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: October 1, 2022
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)