Stable Angina
Conditions
Keywords
clopidogrel, prasugrel, platelet function testing, genotyping, peri-procedural MI
Brief summary
Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.
Interventions
DEVICEGenotyping
Patients harboring CYP2C19 \*2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
DEVICEPhenotyping
Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.
Sponsors
Polish Cardiac Society
University of Pecs
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 18-75 * elective PCI
Exclusion criteria
* acute coronary syndrome (troponin \> 1 x ULN), * administration of glycoprotein IIb/IIIa inhibitors, * chronic total occlusion, * lesions with extensive calcifications requiring rotational atherectomy, * platelet count \<70 000 /µl * high bleeding risk, * coronary bypass surgery in the previous 3 months, * severe chronic renal failure (eGFR \< 30 mL/min) * requirement for warfarin, dabigatran, apixaban, rivaroxaban * history of stroke or TIA, * weight \< 60 kg * known bleeding diathesis, * hematocrit of \< 30% or \>52% * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of periprocedural myocardial injury within 24 h after PCI | Within 24 hours after Percutaneous Coronary Intervention (PCI) | Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients having periprocedural myocardial infarction (MI) | Within 24 hours or PCI | Periprocedural MI is defined as a CK-MB elevation greater than 3x of the upper limit of norm (ULN) within 24 hours of elective PCI. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peak troponin elevation | Within 24 hours of PCI | The level of peak troponin-I elevation during 24 hours of elective PCI |
| Proportion of patients with peri-procedural MI | Within 24 hours of PCI | The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours. |
| BARC type 3 and 5 bleeding | Within 1 week of PCI | BARC-defined type 3 (clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses) and type 5 (fatal) bleeds happening within 7 days of PCI. |
| Death, MI, stent thrombosis (ST) or urgent repeat revascularization | 30 days after PCI | The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI. |
Countries
Hungary, Poland
Contacts
Primary ContactLukasz Koltowski, MD, PhD
Backup ContactMariusz Tomaniak, MD
Outcome results
None listed