Phase 4
N=98
Clopidogrel Monotherapy in Patients With High Bleeding Risk
Bleeding Complications
Bottom Line
View on ClinicalTrials.gov: NCT05223335 ↗Enrolled (actual)
98
Serious AEs
1.0%
Results posted
Feb 2024
Primary outcome: Primary: Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clopidogrel (Drug); Prasugrel (Drug); Tricagrelor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy |
0; 1 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05223335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.