Coronary Stent Implantation, Platelet Inhibition
Conditions
Keywords
clopidogrel-nonresponder, stent thrombosis
Brief summary
The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating on-treatment platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
Detailed description
Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)on-treatment platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.
Interventions
prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
DRUGClopidogrel
clopidogrel 75mg od for 12 month
Sponsors
Kaiser Franz Josef Hospital
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
* all consecutive PCI patients with stent implantation of our institution
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Definite Stent Thrombosis | 30 days | The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis |
| Any Bleeding Event | 30days | Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to \< 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of \> 5 g/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probable Stent Thrombosis | 30days | Probable stent thrombosis is considered to have occurred in case of 1. any unexplained death within the first 30 days. 2. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure |
Countries
Austria
Participant flow
Recruitment details
all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012
Participants by arm
| Arm | Count |
|---|---|
| Standard Therapy standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) | 665 |
| Individualized Therapy dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer | 343 |
| Total | 1,008 |
Baseline characteristics
| Characteristic | Individualized Therapy | Standard Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 174 Participants | 332 Participants | 506 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants | 333 Participants | 502 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 12 | 65 years STANDARD_DEVIATION 12 | 65 years STANDARD_DEVIATION 12 |
| Region of Enrollment Austria | 343 participants | 665 participants | 1008 participants |
| Sex: Female, Male Female | 120 Participants | 183 Participants | 303 Participants |
| Sex: Female, Male Male | 223 Participants | 482 Participants | 705 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 26 / 664 | 18 / 343 |
Outcome results
Primary
Any Bleeding Event
Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to \< 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of \> 5 g/dL
Time frame: 30days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Therapy | Any Bleeding Event | 17 participants |
| Individualized Therapy | Any Bleeding Event | 9 participants |
Primary
Definite Stent Thrombosis
The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Therapy | Definite Stent Thrombosis | 1 participants |
| Individualized Therapy | Definite Stent Thrombosis | 0 participants |
Secondary
Probable Stent Thrombosis
Probable stent thrombosis is considered to have occurred in case of 1. any unexplained death within the first 30 days. 2. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure
Time frame: 30days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Therapy | Probable Stent Thrombosis | 2 participants |
| Individualized Therapy | Probable Stent Thrombosis | 0 participants |