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

17 luglio 2026 aggiornato da: François MACH

A Pilot Study to Investigate Platelet Reactivity in Patients With Elevated Lipoprotein(a) and Its Response to Antiplatelet Therapy Randomised, Open-Label, Mechanistic Pilot Study With A Crossover Design

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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svizzera
      • Geneva, Svizzera, 1205
        • Hôpitaux universitaires de Genève
        • Contatto:
        • Investigatore principale:
          • François Mach, Prof

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Aspirin → Clopidogrel Sequence
Participants receive aspirin 100 mg once daily for 14 days, followed by a 14-day washout period, then clopidogrel 75 mg once daily for 14 days. Platelet function is assessed at baseline and after each treatment period.
Droga: Aspirin
Aspirin 100 mg administered orally once daily for 14 consecutive days during one treatment period of the randomized crossover study. Participants receive aspirin either during Period 1 or Period 2 depending on the randomized treatment sequence. A 14-day washout period separates the two treatment periods.
Droga: Clopidogrel
Clopidogrel 75 mg administered orally once daily for 14 consecutive days during one treatment period of the randomized crossover study. Participants receive clopidogrel either during Period 1 or Period 2 depending on the randomized treatment sequence. A 14-day washout period separates the two treatment periods.
Sperimentale: Clopidogrel → Aspirin Sequence
Participants receive clopidogrel 75 mg once daily for 14 days, followed by a 14-day washout period, then aspirin 100 mg once daily for 14 days. Platelet function is assessed at baseline and after each treatment period.
Droga: Aspirin
Aspirin 100 mg administered orally once daily for 14 consecutive days during one treatment period of the randomized crossover study. Participants receive aspirin either during Period 1 or Period 2 depending on the randomized treatment sequence. A 14-day washout period separates the two treatment periods.
Droga: Clopidogrel
Clopidogrel 75 mg administered orally once daily for 14 consecutive days during one treatment period of the randomized crossover study. Participants receive clopidogrel either during Period 1 or Period 2 depending on the randomized treatment sequence. A 14-day washout period separates the two treatment periods.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in collagen-induced platelet aggregation after aspirin versus clopidogrel treatment
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Within-participant change from baseline in collagen-induced platelet aggregation measured by light transmission aggregometry (LTA) after 14 days of aspirin 100 mg once daily compared with 14 days of clopidogrel 75 mg once daily in the randomized crossover design.
Baseline and Day 14 of each treatment period (up to 42 days)
Change in soluble platelet activation biomarkers after aspirin versus clopidogrel treatment
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Within-participant change from baseline in soluble platelet activation biomarkers (including soluble P-selectin/CD62P, soluble CD40 ligand [sCD40L], platelet factor 4 [PF4], and related biomarkers) following 14 days of aspirin 100 mg once daily compared with 14 days of clopidogrel 75 mg once daily.
Baseline and Day 14 of each treatment period (up to 42 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Agonist-specific platelet aggregation
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Change from baseline in platelet aggregation measured by light transmission aggregometry following stimulation with arachidonic acid, ADP, and TRAP-6 after each treatment period.
Baseline and Day 14 of each treatment period (up to 42 days)
Platelet surface activation markers
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Change from baseline in platelet surface expression of CD62P (P-selectin) and activated GPIIb/IIIa measured by flow cytometry following aspirin and clopidogrel treatment.
Baseline and Day 14 of each treatment period (up to 42 days)
Biochemical verification of aspirin pharmacodynamic effect
Lasso di tempo: Day 14 of the aspirin treatment period
Serum thromboxane B2 (TxB2) concentration measured to verify cyclooxygenase-1 inhibition during aspirin treatment.
Day 14 of the aspirin treatment period
Biochemical verification of clopidogrel pharmacodynamic effect
Lasso di tempo: Day 14 of the clopidogrel treatment period
Vasodilator-stimulated phosphoprotein (VASP) platelet reactivity index (PRI) measured to verify P2Y12 receptor inhibition during clopidogrel treatment.
Day 14 of the clopidogrel treatment period
Association between plasma lipoprotein(a) concentration and platelet function
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Correlation between plasma lipoprotein(a) concentration and platelet function parameters measured by light transmission aggregometry, flow cytometry, and soluble biomarkers.
Baseline and Day 14 of each treatment period (up to 42 days)
Baseline comparison of platelet reactivity between participants with high and low lipoprotein(a)
Lasso di tempo: Baseline (Day 0)
Comparison of baseline platelet function parameters between participants with elevated lipoprotein(a) (>125 nmol/L) and matched participants with low lipoprotein(a) (<25 nmol/L).
Baseline (Day 0)
Plasma proteomic profile associated with lipoprotein(a) and antiplatelet therapy (Exploratory)
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Exploratory analysis of plasma proteins measured using the Olink® proximity extension assay platform to identify proteins associated with elevated lipoprotein(a), platelet reactivity, and treatment with aspirin or clopidogrel.
Baseline and Day 14 of each treatment period (up to 42 days)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Identification of candidate biomarkers associated with lipoprotein(a)-related platelet hyperreactivity
Lasso di tempo: Baseline and Day 14 of each treatment period (up to 42 days)
Exploratory identification of circulating protein biomarkers associated with platelet hyperreactivity and pharmacodynamic response to aspirin and clopidogrel using Olink® proteomic analysis. Results are hypothesis-generating only.
Baseline and Day 14 of each treatment period (up to 42 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

François MACH

Collaboratori

University Hospital, Geneva

Investigatori

  • Investigatore principale: François Mach, Prof, HUG

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

17 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-01415

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data collected during the Lp(a)-PLAT study, including clinical data, laboratory results, and platelet function measurements, will not be shared in public data repositories.

Given the mechanistic nature of the study and the small sample size, there is a potential risk of indirect re-identification of participants even after standard anonymisation procedures. Therefore, raw participant-level datasets will remain under controlled access within the Sponsor institution (Hôpitaux Universitaires de Genève, HUG).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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