Status:
COMPLETED
Clopidogrel Monotherapy in Patients With High Bleeding Risk
Lead Sponsor:
Mayo Clinic
Conditions:
Bleeding Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05223335
Start Date
March 29 2022
End Date
March 16 2023
Last Update
February 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905