Coronary Artery Disease, Thrombosis
Conditions
Brief summary
Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting
Interventions
DRUGPrasugrel
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
DRUGClopidogrel
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography. * Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for \>5 days) * Age range 21-75 years.
Exclusion criteria
* Unable to give consent * Age younger than 21 years, greater than 75 years * History of stroke * Body weight \<60 kg * Acute STEMI, * Thrombocytopenia\<100'000, * requirement for chronic warfarin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombelastography (TEG) MA | 1 day | Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ischemic Events | 6 months | Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention |
| Number of Participants With Bleeding Events | 6 months | Major or Minor Bleeding according to TIMI criteria |
Countries
United States
Participant flow
Pre-assignment details
67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.
Participants by arm
| Arm | Count |
|---|---|
| Thrombelastography (TEG) Guided Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder | 19 |
| Light Transmittance Aggregometry Guided Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9%
Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Thrombelastography (TEG) Guided | Total | Light Transmittance Aggregometry Guided |
|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 9.8 | 54.2 years STANDARD_DEVIATION 10 | 53.2 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 22 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 15 Participants | 10 Participants |
| Region of Enrollment United States | 19 participants | 37 participants | 18 participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Thrombelastography (TEG) MA
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Time frame: 1 day
Population: TEG-MA (mm) at 16-24 hours outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thrombelastography (TEG) Guided | Thrombelastography (TEG) MA | 66.4 mm | Standard Deviation 11 |
| Light Transmittance Aggregometry Guided | Thrombelastography (TEG) MA | 65.8 mm | Standard Deviation 6.9 |
p-value: 0.85t-test, 2 sided
Secondary
Number of Participants With Bleeding Events
Major or Minor Bleeding according to TIMI criteria
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thrombelastography (TEG) Guided | Number of Participants With Bleeding Events | Bleeding | 0 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Bleeding Events | No Bleeding | 19 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Bleeding Events | Bleeding | 0 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Bleeding Events | No Bleeding | 18 Participants |
p-value: >0.05Chi-squared
Secondary
Number of Participants With Ischemic Events
Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Time frame: 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Death | Event | 0 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Myocardial Infarction | Event | 1 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Recurrent coronary intervention | No Event | 16 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Death | No Event | 19 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Unstable Angina | Event | 2 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Myocardial Infarction | No Event | 18 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Unstable Angina | No Event | 17 Participants |
| Thrombelastography (TEG) Guided | Number of Participants With Ischemic Events | Recurrent coronary intervention | Event | 3 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Unstable Angina | No Event | 16 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Death | Event | 0 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Death | No Event | 18 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Myocardial Infarction | Event | 0 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Myocardial Infarction | No Event | 18 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Recurrent coronary intervention | Event | 2 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Recurrent coronary intervention | No Event | 16 Participants |
| Light Transmittance Aggregometry Guided | Number of Participants With Ischemic Events | Unstable Angina | Event | 2 Participants |
p-value: 0.93Chi-squared