Clopidogrel Monotherapy in Patients With High Bleeding Risk

Study Overview
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Brief Summary
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The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).

Official Title
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Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding

Conditions
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Bleeding Complications

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Prasugrel
* Drug: Tricagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent in adults Successful percutaneous coronary intervention (PCI) [no non-fatal MI/stroke/repeat target revascularization/bleeding/acute kidney injury]. Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4. Exclusion Criteria: Chronic use of warfarin or direct oral anticoagulant (DOAC). Unsuccessful PCI (see above). Lesions with angiographic thrombus. Prior PCI within 6 months. Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months. High risk lesion/stent characteristics (> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy. Vein graft. Unprotected left main intervention or history of definite stent thrombosis. Women of child-bearing age unless negative pregnancy test is done. Life expectancy < 1 year. Known drug/alcohol dependence. Assessment that the patient will not be compliant with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotype-Guided Therapy<br>Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy. | Drug: Prasugrel<br>* 60 mg bolus then 10 mg daily<br>Drug: Tricagrelor<br>* 180 mg bolus then 90 mg twice daily<br>|
| Active Comparator: Conventional Therapy<br>Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers will continue with clopidogrel monotherapy. | Drug: Clopidogrel<br>* 75 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic risk post-PCI in high bleed risk patients with genotype-guided single antiplatelet therapy | The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI). | Through study completion, approximately 90 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelet medications, Blood thinners, Stent thrombosis, Percutaneous Coronary Intervention