Clopidogrel Monotherapy After PCI in Patients with High Bleeding Risk
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-011053
NCT ID: NCT05223335
Sponsor Protocol Number: 21-011053
About this study
The primary aims of this study are to test the hypothesis that clopidogrel monotherapy is safe following successful PCI among 100 consecutive patients with HBR and meeting the inclusion criteria, and to determine the incidence of BARC 3 or 5 bleeding events among participants enrolled in Aims 1 and 2.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mandeep Singh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available