A Pilot Study to Investigate Platelet Reactivity in Patients With Elevated Lipoprotein(a) and Its Response to Antiplatelet Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrançois MACH

About this trial

The Lp(a)-PLAT Study is designed to close a critical evidence gap in cardiovascular prevention for the roughly 20% of the population who carry genetically determined elevations in lipoprotein(a) - a recognised pro-thrombotic and pro-atherosclerotic risk factor. Its objective is to delineate the pro-thrombotic platelet phenotype driven by high Lp(a) levels and to evaluate, through pharmacodynamic comparison, how two standard-of-care antiplatelet strategies - clopidogrel, a P2Y12 ADP-receptor inhibitor, and aspirin, a COX-1 inhibitor - differ in their capacity to attenuate this platelet hyperreactivity.

This study will provide the first head-to-head mechanistic comparison of clopidogrel versus aspirin on platelet reactivity in patients with elevated plasma levels of Lp(a).

Eligibility criteria

Qualifiers

Age ≥ 18 years at the time of informed consent.

Ability to provide written informed consent in accordance with Swiss Human Research Act (HRA) and ICH-GCP.

Clinically stable at the time of inclusion, with no acute cardiovascular event within the previous 3 months.

Willingness and ability to comply with all study procedures, including blood sampling and study medication intake.

Disqualifiers

Cardiovascular and bleeding-related conditions Active bleeding or known bleeding disorder. History of hemorrhagic stroke or intracranial hemorrhage. High risk of bleeding as judged by the investigator. Platelet count < 100 × 10⁹/L at screening. Known platelet function disorder.

Contraindications to study medications Known hypersensitivity or contraindication to aspirin (acetylsalicylic acid) or clopidogrel.

Trial design

Treatments tested in this trial

  • Aspirin
  • Clopidogrel

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

François MACH

Lead sponsor

University Hospital, Geneva

Sponsor institution

University Hospital, Geneva

Collaborator