A Phase 2 interventional study of Clopidogrel in Acute Coronary Syndrome and CYP2C19 Polymorphism, sponsored by St. Antonius Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by St. Antonius Hospital · Phase 2, Interventional, and Treatment
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:
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.
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:
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →St. Antonius Hospital is the lead sponsor of 94 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
In 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.
Drug: Clopidogrel
See arm description earlier.
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)
Time frame: 6 months
Primary safety endpoint
Composite endpint consisting of major or clinically relevant non-major bleeding (BARC type 2, 3 or 5 bleeding)
Time frame: 6 months
Mortality
all-cause mortality
Time frame: 3 and 6 months
Myocardial infarction
Myocardial infarction
Time frame: 3 and 6 months
Stent thrombosis
Probable and definite Stent Thrombosis
Time frame: 3 and 6 months
Ischemic stroke
ischemic stroke
Time frame: 3 and 6 months
Major bleeding
BARC 3 or 5 bleeding
Time frame: 3 and 6 months
Major bleeding
BARC 3 bleeding
Time frame: 3 and 6 months
Clinically relevant non-major bleeding
BARC 2 bleeding
Time frame: 3 and 6 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Antonius Hospital