Cardiovascular PreventionLp(a)-PLATNCT07720934
A Pilot Study to Investigate Platelet Reactivity in Patients With Elevated Lipoprotein(a) and Its Response to Antiplatelet Therapy
A study testing Aspirin and Clopidogrel in people with Cardiovascular Prevention, run by François MACH at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Prevention
- What is being tested?
- Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Hopitaux Universitaires de Genève
Geneva, 1205
Véronique Menoni, PhD, 0223729195 ext. +41, veronique.menoni@hug.ch
François Mach, Prof
About this study
Official title: 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).
- Conditions
- Cardiovascular Prevention
- Being tested
- Aspirin, Clopidogrel
- Keywords
- Lipoprotein(a)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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.
ClopidogrelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin → Clopidogrel Sequence | Experimental | 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. Receives: Drug: Aspirin; Drug: Clopidogrel |
| Clopidogrel → Aspirin Sequence | Experimental | 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. Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in collagen-induced platelet aggregation after aspirin versus clopidogrel treatment
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.
Measured: Baseline and Day 14 of each treatment period (up to 42 days)
Change in soluble platelet activation biomarkers after aspirin versus clopidogrel treatment
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.
Measured: Baseline and Day 14 of each treatment period (up to 42 days)
Secondary outcomes (7)
Agonist-specific platelet aggregation
Change from baseline in platelet aggregation measured by light transmission aggregometry following stimulation with arachidonic acid, ADP, and TRAP-6 after each treatment period.
Measured: Baseline and Day 14 of each treatment period (up to 42 days)
Platelet surface activation markers
Change from baseline in platelet surface expression of CD62P (P-selectin) and activated GPIIb/IIIa measured by flow cytometry following aspirin and clopidogrel treatment.
Measured: Baseline and Day 14 of each treatment period (up to 42 days)
Biochemical verification of aspirin pharmacodynamic effect
Serum thromboxane B2 (TxB2) concentration measured to verify cyclooxygenase-1 inhibition during aspirin treatment.
Measured: Day 14 of the aspirin treatment period
Biochemical verification of clopidogrel pharmacodynamic effect
Vasodilator-stimulated phosphoprotein (VASP) platelet reactivity index (PRI) measured to verify P2Y12 receptor inhibition during clopidogrel treatment.
Measured: Day 14 of the clopidogrel treatment period
Association between plasma lipoprotein(a) concentration and platelet function
Correlation between plasma lipoprotein(a) concentration and platelet function parameters measured by light transmission aggregometry, flow cytometry, and soluble biomarkers.
Measured: 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)
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).
Measured: Baseline (Day 0)
Plasma proteomic profile associated with lipoprotein(a) and antiplatelet therapy (Exploratory)
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.
Measured: Baseline and Day 14 of each treatment period (up to 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- François MACH
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, François MACH, University Hospital, Geneva
- Investigators
- François Mach, Prof, Principal investigator, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720934
- Sponsor's protocol ID
- 2026-01415
- Acronym
- Lp(a)-PLAT
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07720934
- Acronym / sponsor ID
- Lp(a)-PLAT / 2026-01415
- Conditions
- Cardiovascular Prevention
- Keywords
- Lipoprotein(a)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- François MACHUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin → Clopidogrel Sequence | Experimental | Drug: Aspirin, Drug: ClopidogrelParticipants 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. |
| Clopidogrel → Aspirin Sequence | Experimental | Drug: Aspirin, Drug: ClopidogrelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 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. | Drug | Aspirin → Clopidogrel Sequence, Clopidogrel → Aspirin Sequence |
| ClopidogrelClopidogrel 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. | Drug | Aspirin → Clopidogrel Sequence, Clopidogrel → Aspirin Sequence |
Primary outcome
Change in collagen-induced platelet aggregation after aspirin versus clopidogrel treatment
Time frame: 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.
Change in soluble platelet activation biomarkers after aspirin versus clopidogrel treatment
Time frame: 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.
7 secondary outcomes
Agonist-specific platelet aggregation
Time frame: Baseline and Day 14 of each treatment period (up to 42 days)
Platelet surface activation markers
Time frame: Baseline and Day 14 of each treatment period (up to 42 days)
Biochemical verification of aspirin pharmacodynamic effect
Time frame: Day 14 of the aspirin treatment period
Biochemical verification of clopidogrel pharmacodynamic effect
Time frame: Day 14 of the clopidogrel treatment period
Association between plasma lipoprotein(a) concentration and platelet function
Time frame: 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)
Time frame: Baseline (Day 0)
Plasma proteomic profile associated with lipoprotein(a) and antiplatelet therapy (Exploratory)
Time frame: Baseline and Day 14 of each treatment period (up to 42 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Mach, Prof principal investigator
HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Clopidogrel in people with Cardiovascular Prevention, run by François MACH at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kapka Miteva, PhD (+41 22 379 4648, Kapka.Miteva@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in collagen-induced platelet aggregation after aspirin versus clopidogrel treatment (time frame: Baseline and Day 14 of each treatment period (up to 42 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.