Clopidogrel Monotherapy in Patients With High Bleeding Risk

Phase 4

Completed

• Conditions: Bleeding Complications
• Interventions: Drug: Prasugrel; Drug: Clopidogrel; Drug: Tricagrelor

• Registration Number: NCT05223335
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-03
• Study Start: 2022-03-29
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Results First Submitted: 2024-01-17
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Results First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Informed consent in adults
• Successful percutaneous coronary intervention (PCI) [no non-fatal myocardial infarction (MI)/stroke/repeat target revascularization/bleeding/acute kidney injury].
• Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype-Guided Therapy	Tricagrelor	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 loss-of-function (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.
Genotype-Guided Therapy	Prasugrel	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 loss-of-function (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.
Conventional Therapy	Clopidogrel	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 loss-of-function (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.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States