Assessing clopidogrel use before elective heart procedures
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
This study is testing whether giving a clopidogrel dose before heart procedures helps patients with coronary artery disease feel better and have safer outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1462 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam, Noord-Holland and 1 other locations) |
| Trial ID | NCT05559918 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of administering a clopidogrel loading dose in the laboratory prior to elective percutaneous coronary intervention (PCI) compared to preloading treatment. It focuses on patients scheduled for diagnostic coronary angiography who may require ad-hoc PCI. The study aims to gather real-world data on these treatment strategies to inform best practices in managing coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for diagnostic coronary angiography due to suspected obstructive coronary artery disease.
Not a fit: Patients with contraindications to clopidogrel or those using alternative antiplatelet medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize antiplatelet therapy for patients undergoing elective PCI, potentially improving outcomes and safety.
How similar studies have performed: Other studies have explored antiplatelet strategies in PCI, but this specific approach in a real-world setting is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, Noord-Holland and 1 other locations
- Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Ronak Delewi, MD, PhD — Amsterdam University Medical Center, location AMC
- Study coordinator: Ronak Delewi, MD, PhD
- Email: r.delewi@amsterdamumc.nl
- Phone: +31(0)20 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.