Clopidogrel Monotherapy in Patients With High Bleeding Risk

Mayo Clinic98 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bleeding Complications

Interventions

ClopidogrelDRUG

75 mg/day

PrasugrelDRUG

60 mg bolus then 10 mg daily

TricagrelorDRUG

180 mg bolus then 90 mg twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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).

Time frame: Through study completion, approximately 90 days.

Data from ClinicalTrials.gov

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