Efficacy, Safety and Tolerability of PrasugrEl 5mg or TIcagrelor 60mg in COmplex and Higher-Risk Indicated PCI/PatieNts
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0004788
- Lead Sponsor
- Gyeongsang National University Changwon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 492
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Platelet function test, Bleeding assessment, Dyspnea assessment