Last updated: January 28, 2021
Sponsor: Gyeongsang National University Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Thrombosis
Atherosclerosis
Hypercholesterolemia
Treatment
N/AClinical Study ID
NCT04734353
E-5TION
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 19 and more; and
- Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk®drug-eluting stent
- At least one of the following high-risk factors;
- Clinical factors: diabetes, chronic kidney disease (GFR < 60ml/min/1.73m2), LVdysfunction (LV EF < 45%), or troponin (+).
- Lesion- or procedure-related factors: left main PCI, chronic totalocclusion, bifurcation lesion requiring two-stent technique, severecalcification, in-stent restenosis, multi-vessel PCI (≥ 2 vessels requiringstent implantation), PCI for ≥ 3 lesions, ≥ 3 stents implanted, or totalstent length > 60 mm.
- High platelet reactivity: VerifyNow PRU ≥ 266.
Exclusion
Exclusion Criteria:
- Cardiogenic shock at the index admission
- Bleeding tendency, congenital or acquired
- Active bleeding or high-risk for major bleeding (e.g. active peptic ulcer disease,gastrointestinal pathology with a high-risk for bleeding, malignancies with ahigh-risk for bleeding)
- Need for chronic oral anticoagulation
- History of intracranial hemorrhage
- Intracranial neoplasm, AV fistula or aneurysm
- Platelet counts < 100,000/mm3
- Liver cirrhosis with ascites or coagulopathy
- Dialysis-impending or -dependent renal failure
- Pregnant and/or lactating women
- Increased risk of bradycardia events (sick sinus, AV block grade II or III,bradycardia-induced syncope)
- 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), CYP3Asubstrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strongCYP3A inducers (e.g., rifampin/ rifampicin, phenytoin, carbamazepine, dexamethason,phenobarbital) that cannot be safely discontinued
- Concurrent medical condition with a life expectancy of less than 1 years
Study Design
Total Participants: 492
Study Start date:
January 15, 2020
Estimated Completion Date:
June 15, 2022
Study Description
Connect with a study center
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do 51472
Korea, Republic ofActive - Recruiting
Gyeongsang National University Hospita
Jinju, Gyeongsangnam-do
Korea, Republic ofActive - Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do 626-770
Korea, Republic ofActive - Recruiting
Dong-A University Hospital
Busan, 602-714
Korea, Republic ofSite Not Available
Inje University Busan Paik Hospital,
Busan,
Korea, Republic ofSite Not Available
Kosin University Gospel Hospital
Busan, 602-702
Korea, Republic ofSite Not Available
Pusan National University Hospital,
Busan, 602-739,
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan,
Korea, Republic ofSite Not Available
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