Clopidogrel Monotherapy in Patients With High Bleeding Risk

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Clopidogrel; Prasugrel Hydrochloride

Criteria

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.