A Pilot Study to Investigate Platelet Reactivity in Patients With Elevated Lipoprotein(a) and Its Response to Antiplatelet Therapy
Starting soon · Not applicable
Conditions studied: Cardiovascular Prevention
In brief
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).
Key facts
- Study ID
- NCT07720934
- Run by
- François MACH
- People needed
- 60
- Starts
- 2026-11-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Documented plasma lipoprotein(a) [Lp(a)] concentration:
- High Lp(a) cohort: ≥ 125 nmol/L (approximately ≥ 75th percentile) Low Lp(a) comparator cohort (if applicable): < 25-30 nmol/L
- 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.
- For women of childbearing potential: willingness to use adequate contraception during the study period (if applicable according to local ethics requirements).
You may not qualify if…
- 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.
- History of aspirin-induced asthma, severe NSAID intolerance, or anaphylactic reaction to salicylates.
- Active peptic ulcer disease or clinically significant gastrointestinal bleeding within the past 6 months.
- Concomitant medications and interference with platelet function Current use of dual antiplatelet therapy (DAPT), oral anticoagulants (e.g., DOACs, vitamin K antagonists), or other potent antithrombotic agents that cannot be safely interrupted.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days prior to study entry (unless discontinued per protocol).
- Use of P2Y12 inhibitors or aspirin within an insufficient washout period. - Clinical conditions Severe hepatic impairment (ALT/AST > 3× ULN) or severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Active malignancy requiring systemic chemotherapy. Known hematologic disorder affecting platelet function or coagulation. Acute infection or inflammatory condition likely to affect platelet function.
- Other exclusions Pregnancy or breastfeeding. Participation in another interventional clinical trial within the last 30 days or 5 half-lives of the investigational product, whichever is longer.
- Any condition that, in the opinion of the investigator, would interfere with study participation, compliance, or interpretation of results.
Where it is running
- Hopitaux Universitaires de Genève — Geneva, Switzerland
Full record on ClinicalTrials.gov
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