Clopidogrel Monotherapy in Patients With High Bleeding Risk
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Genotype-Guided Therapy 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
60 mg bolus then 10 mg daily
Drug: Tricagrelor
180 mg bolus then 90 mg twice daily
|
Active Comparator: Conventional Therapy 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
75 mg/day
|
Outcome Measures
Primary Outcome Measures
- Ischemic risk post-PCI in high bleed risk patients with genotype-guided single antiplatelet therapy [Through study completion, approximately 90 days.]
The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent in adults
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Successful percutaneous coronary intervention (PCI) [no non-fatal MI/stroke/repeat target revascularization/bleeding/acute kidney injury].
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Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.
Exclusion Criteria:
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Chronic use of warfarin or direct oral anticoagulant (DOAC).
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Unsuccessful PCI (see above).
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Lesions with angiographic thrombus.
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Prior PCI within 6 months.
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Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months.
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High risk lesion/stent characteristics (> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy.
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Vein graft.
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Unprotected left main intervention or history of definite stent thrombosis.
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Women of child-bearing age unless negative pregnancy test is done.
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Life expectancy < 1 year.
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Known drug/alcohol dependence.
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Assessment that the patient will not be compliant with the study protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Mandeep Singh, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-011053