Bleeding Complications
Conditions
Keywords
Antiplatelet medications, Blood thinners, Stent thrombosis, Percutaneous Coronary Intervention
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).
Interventions
DRUGClopidogrel
75 mg/day
DRUGPrasugrel
60 mg bolus then 10 mg daily
DRUGTricagrelor
180 mg bolus then 90 mg twice daily
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy | Through study completion, approximately 90 days. | The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Genotype-Guided Therapy Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19\*2 or\*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy.
Prasugrel: 60 mg bolus then 10 mg daily
Tricagrelor: 180 mg bolus then 90 mg twice daily | 29 |
| Conventional Therapy Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19\*2 or\*3 LOF allele non-carriers continued with clopidogrel monotherapy.
Clopidogrel: 75 mg/day | 69 |
| Total | 98 |
Baseline characteristics
| Characteristic | Genotype-Guided Therapy | Total | Conventional Therapy |
|---|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 11.7 | 74.6 years STANDARD_DEVIATION 11.1 | 75.3 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 98 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 94 Participants | 68 Participants |
| Region of Enrollment United States | 29 participants | 98 participants | 69 participants |
| Sex: Female, Male Female | 11 Participants | 34 Participants | 23 Participants |
| Sex: Female, Male Male | 18 Participants | 64 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 69 |
| other Total, other adverse events | 0 / 29 | 3 / 69 |
| serious Total, serious adverse events | 0 / 29 | 1 / 69 |
Outcome results
Primary
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).
Time frame: Through study completion, approximately 90 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Genotype-Guided Therapy | Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy | 0 Participants |
| Conventional Therapy | Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy | 1 Participants |