None listed
Conditions
Interventions
Drug : - Arms and Interventions
* Arms
Experimental: E5 group
Prasugrel 20 mg loading, then followed by prasugrel 5 mg a day
* Assigned Interventions
Drug: Tailored antiplatelet treatment
E5 group: p
Sponsors
Gyeongsang National University Changwon Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 19 and more 2. Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent 3. At least one of the following high-risk factors; 1) Clinical factors: diabetes, chronic kidney disease (GFR < 60ml/min/1.73m2), LV dysfunction (LV EF < 45%), or troponin (+). 2) Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, in-stent restenosis, multi-vessel PCI (= 2 vessels requiring stent implantation), PCI for = 3 lesions, = 3 stents implanted, or total stent length > 60 mm. 3) High platelet reactivity: VerifyNow PRU = 266.
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock at the index admission 2. Bleeding tendency, congenital or acquired 3. Active bleeding or high-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high-risk for bleeding, malignancies with a high-risk for bleeding) 4. Need for chronic oral anticoagulation 5. History of intracranial hemorrhage 6. Intracranial neoplasm, AV fistula or aneurysm 7. Platelet counts < 100,000/mm3 8. Liver cirrhosis with ascites or coagulopathy 9. Dialysis-impending or -dependent renal failure 10. Pregnant and/or lactating women 11. Increased risk of bradycardia events (sick sinus, AV block grade II or III, bradycardia-induced syncope) 12. Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin/ rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital) that cannot be safely discontinued 13. Concurrent medical condition with a life expectancy of less than 1 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major bleeding((BARC type 2, 3 or 5) and discontinuation/switch of antiplatelet regimen;ISTH major bleeding or clinically relevant non-major bleeding, cardiovascular death, myocardial infarction, stent thrombosis, stroke or urgent revascularizationcardiovascular death, myocardial infarction, stent thrombosis, stroke or urgent revascularization | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet function test, Bleeding assessment, Dyspnea assessment | — |
Countries
Korea, Republic of
Contacts
Public Contacthee jeong nam
Gyeongsang National University Changwon Hospital
Outcome results
None listed