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Acute Coronary SyndromePhase 2POPular GUILTYNCT05926271

POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy

A Phase 2 study testing Clopidogrel in people with Acute Coronary Syndrome and CYP2C19 Polymorphism, run by St. Antonius Hospital at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Coronary Syndrome, CYP2C19 Polymorphism
What is being tested?
Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteNetherlands
Study dates
15 Jul 2023to 15 Jan 2027
Phase
Phase 2
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

  • Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met:
  • Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
  • Successful PCI (according to the treating physician) with implantation of new generation drug eluting stents.
  • CYP2C19 extensive or ultra-rapid metabolizer

Who cannot join

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • CYP2C19 poor or intermediate metabolizer
  • Known allergy or contraindication for aspirin or clopidogrel.
  • Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
  • Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
  • High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, ≥3 treated vessels, ≥ 3 stents implanted and total stent length >60 mm
Show all 12Show fewer
  • Recent stroke, transient ischemic attack (TIA) or intracranial bleeding
  • Severe hepatic impairment (Child Pugh class C)
  • Planned surgical intervention within 6 months of PCI
  • Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)
  • Pregnant or breastfeeding women at time of enrolment
  • Participation in another trial with an investigational drug or device

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jaouad Azzahhafi, MD contact

+31883201321

j.azzahhafi@antoniusziekenhuis.nl

Jurrien ten Berg, MD PhD contact

+31883201321

j.ten.berg@antoniusziekenhuis.nl

Netherlands1 site, 1 recruiting

  • St. Antonius Hospital

    Nieuwegein, Utrecht

    Prof. J.M. ten Berg, MD, PhD, MSc

    Recruiting

Other trials in Netherlands

About this study

The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). The main questions it aims to answer are:

  • Is genotype-guided clopidogrel monotherapy effective in reducing ischemic risk during the first six months following successful PCI?
  • Is genotype-guided clopidogrel monotherapy safe in terms of reducing bleeding risk during the first six months following successful PCI?
Read more

Participants will be given genotype-guided clopidogrel monotherapy after their successful PCI procedure and will be monitored for any bleeding or ischemic complications over the next six months.

Researchers will compare these results to the typical outcomes associated with traditional Dual antiplatelet therapy (DAPT) to see if genotype-guided clopidogrel monotherapy provides similar or improved protection from ischemic events, but with fewer bleeding complications.

Read the detailed description

Rationale: Dual antiplatelet therapy (DAPT) consisting of aspirin and a P2Y12 inhibitor is the cornerstone of treatment in patients receiving coronary stent implantation, reducing the risk of stent thrombosis (ST), myocardial infarction (MI) and stroke. However, the need for aspirin is currently challenged as both technical and pharmaceutical advancements reduced atherothrombotic complications such as ST and MI after percutaneous coronary intervention (PCI) and DAPT is associated with bleeding complications. Single antiplatelet therapy (SAPT) after a 1-3 month period of DAPT demonstrated fewer bleeding complications with a similar level of ischemic complications. In addition, potent P2Y12 inhibitor monotherapy was deemed safe without any ST in a pilot study and is currently being investigated in a randomized controlled clinical trial. Since clopidogrel is equally effective in prevention of ischemic complications to ticagrelor and prasugrel in CYP2C19 extensive or ultra-rapid metabolizers, while causing less bleeding complications, this pilot study will explore the safety of genotype-guided clopidogrel monotherapy in CYP2C19 extensive or ultra-rapid metabolizers presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) undergoing successful PCI.

Hypothesis:

Genotype-guided clopidogrel monotherapy is safe in regards to bleeding and ischemic endpoints in NSTE-ACS patients undergoing successful PCI.

Objective:

  1. To assess ischemic risk (i.e. efficacy) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
  2. To assess bleeding risk (i.e. safety) of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients.
Being tested
Clopidogrel
Keywords
Acute coronary syndrome, Monotherapy, P2Y12 inhibitor, Aspirin free strategy
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05926271
Study groupRoleWhat they receive
Genotype guided armExperimentalIn this study arm, patients with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who are extensive or ultra-rapid metabolizers as per their CYP2C19 genotype and have undergone successful percutaneous coronary intervention (PCI) will receive a genotype-guided monotherapy. The intervention will be clopidogrel, a potent P2Y12 inhibitor, administered in accordance with the patient's specific genotype. Clopidogrel following PCI will be given with an initial loading dose (300-600mg orally), followed by a maintenance dose of 75mg daily for a defined period, at least 6 months.
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint

    A composite endpoint consisting of all-cause mortality, myocardial infarction, probable and definite Stent Thrombosis and ischemic stroke (the first event that occurs will be counted for this composite endpoint)

    Measured: 6 months

  2. Primary safety endpoint

    Composite endpint consisting of major or clinically relevant non-major bleeding (BARC type 2, 3 or 5 bleeding)

    Measured: 6 months

Secondary outcomes (7)

  1. Mortality

    all-cause mortality

    Measured: 3 and 6 months

  2. Myocardial infarction

    Myocardial infarction

    Measured: 3 and 6 months

  3. Stent thrombosis

    Probable and definite Stent Thrombosis

    Measured: 3 and 6 months

  4. Ischemic stroke

    ischemic stroke

    Measured: 3 and 6 months

  5. Major bleeding

    BARC 3 or 5 bleeding

    Measured: 3 and 6 months

  6. Major bleeding

    BARC 3 bleeding

    Measured: 3 and 6 months

  7. Clinically relevant non-major bleeding

    BARC 2 bleeding

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start15 Jul 2023
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This pilot, genotype-guided clinical trial aims to assess the safety and efficacy of clopidogrel monotherapy in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients post-successful percutaneous coronary intervention (PCI). Participants, identified as extensive or ultra-rapid metabolizers by CYP2C19 genotype, will receive clopidogrel monotherapy. The primary outcomes include the ischemic risk (efficacy) and bleeding risk (safety) during the first six months post-PCI. The trial hypothesizes that genotype-guided clopidogrel monotherapy is safe and efficacious in mitigating bleeding and ischemic complications.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05926271
Sponsor's protocol ID
NL82555.100.22
Acronym
POPular GUILTY
Status last verified
Nov 2024
First submitted
7 Jun 2023
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clopidogrel in people with Acute Coronary Syndrome and CYP2C19 Polymorphism, run by St. Antonius Hospital at 1 site in Netherlands.

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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. 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 Netherlands. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jaouad Azzahhafi, MD (+31883201321, j.azzahhafi@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT05926271.

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 3 Dec 2024.

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