Back to resultsClopidogrel Monotherapy in Patients With High Bleeding Risk
Primary Purpose
Bleeding Complications
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clopidogrel
Prasugrel
Tricagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Complications focused on measuring Antiplatelet medications, Blood thinners, Stent thrombosis, Percutaneous Coronary Intervention
Eligibility 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Genotype-Guided Therapy
Conventional Therapy
Arm Description
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy.
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers will continue with clopidogrel monotherapy.
Outcomes
Primary Outcome Measures
Ischemic risk post-PCI in high bleed risk patients with genotype-guided single antiplatelet therapy
The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05223335
Brief Title
Clopidogrel Monotherapy in Patients With High Bleeding Risk
Official Title
Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Complications
Keywords
Antiplatelet medications, Blood thinners, Stent thrombosis, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genotype-Guided Therapy
Arm Type
Experimental
Arm Description
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 LOF allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers will continue with clopidogrel monotherapy.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75 mg/day
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
60 mg bolus then 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Tricagrelor
Intervention Description
180 mg bolus then 90 mg twice daily
Primary Outcome Measure Information:
Title
Ischemic risk post-PCI in high bleed risk patients with genotype-guided single antiplatelet therapy
Description
The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI).
Time Frame
Through study completion, approximately 90 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandeep Singh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Clopidogrel Monotherapy in Patients With High Bleeding Risk
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