Clopidogrel Monotherapy in Patients With High Bleeding Risk

  • STATUS
    Recruiting
  • End date
    Mar 27, 2024
  • participants needed
    100
  • sponsor
    Mayo Clinic
Updated on 27 April 2022

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).

Details
Condition Bleeding Complications
Treatment Clopidogrel, prasugrel, Tricagrelor
Clinical Study IdentifierNCT05223335
SponsorMayo Clinic
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
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