Clopidogrel Monotherapy in Patients With High Bleeding Risk

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Bleeding Complications

Treatments: Drug: Tricagrelor; Drug: Prasugrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT05223335

21-011053

Details and patient eligibility

About

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).

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Genotype-Guided Therapy

Experimental group

Description:

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.

Treatment:

Drug: Prasugrel

Drug: Tricagrelor

Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Clopidogrel