Coronary Stenoses Clinical Trial
— TAILORED-CHIPOfficial title:
Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention
Verified date | January 2024 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).
Status | Active, not recruiting |
Enrollment | 2031 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Age 19 and more 2. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent 3. At least one of the following high-risk clinical, lesion or procedure-related risk factors; - Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or - Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length = at least 30 mm), multi-vessel PCI (= 2 vessels requiring stent implantation), =3 requiring stent implantation, = 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm Exclusion Criteria: 1. Enzyme-positive Acute myocardial infarction(NSTEMI or STEMI) 2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) 3. Subject using Gp IIb/IIIa inhibitors at randomization 4. Cardiogenic shock or Severe LV dysfunction(LV ejection fraction <30%) at the index admission 5. Subject treated with only BMS or balloon angioplasty during the index procedure. 6. Need for chronic oral anticoagulation (warfarin or NOACs) 7. Active bleeding or extreme-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) 8. History of intracranial hemorrhage or intra cranial aneurysm 9. Planned surgery within 180 days 10. Subjects with Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening who meet the following criteria 1) Platelet count < 80,000 cells/mm3 2) Hb <10 g/dL 11. Subject at risk of bradycardia (Subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but not inserted permanent pacemaker) 12. Subjects taking strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment : Ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital 13. Pregnant and/or lactating women. 14. Concurrent medical condition with a life expectancy of less than 1 years 15. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 16. Subject was unable to provide written informed consent or participate in long-term follow-up. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Bucheon | |
Korea, Republic of | Gyeongsang National University Changwon Hospital | Changwon | |
Korea, Republic of | Chungbuk National University Hospital | Cheonju | |
Korea, Republic of | Gangwon National Univ. Hospital | Chuncheon | |
Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Gangneung Asan Hospital | Gangneung | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Dong-A Medical Center | Pusan | |
Korea, Republic of | Inje University Pusan Paik Hospital | Pusan | |
Korea, Republic of | Pusan National University Hospital | Pusan | |
Korea, Republic of | Bundang CHA Hospital | Seongnam | |
Korea, Republic of | Seoul university Bundang hospital | Seongnam-si | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Chung-Ang University Hospital | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | The Catholic Univ. of Korea Eunpyeong St. Mary's hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | |
Korea, Republic of | St.Carollo Hospital | Suncheon | |
Korea, Republic of | The Catholic University of Korea, ST. Mary's Hospital | Suwon | |
Korea, Republic of | Ulsan University Hospital | Ulsan |
Lead Sponsor | Collaborator |
---|---|
Duk-Woo Park, MD | CardioVascular Research Foundation, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net clinical outcome | a net clinical outcome of all-cause death, MI, stroke, stent thrombosis, urgent revascularization and clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months post-PCI. | 1 year | |
Secondary | All-cause death | 1 year | ||
Secondary | Myocardial infarction | 1 year | ||
Secondary | Stroke | 1 year | ||
Secondary | Stent thrombosis | 1 year | ||
Secondary | Urgent revascularization | 1 year | ||
Secondary | Clinically relevant bleeding | Bleeding Academic Research Consortium (BARC) 2, 3, or 5 | 1 year | |
Secondary | Composite of death (all or cardiovascular), MI, or stroke, stent thrombosis or urgent revascularization | 1 year | ||
Secondary | Composite of death (all or cardiovascular), MI, or stroke | 1 year | ||
Secondary | Composite of death (all or cardiovascular) or MI | 1 year | ||
Secondary | Any revascularization | 1 year | ||
Secondary | BARC type 3 or 5 bleeding | 1 year | ||
Secondary | Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI) | 1 year | ||
Secondary | Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH) | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02951949 -
Estrogen Exposure and Atherosclerosis in Postmenopausal Women
|
||
Enrolling by invitation |
NCT02931331 -
Coronary Revascularization Assessed by Stress PET
|
N/A | |
Active, not recruiting |
NCT02978456 -
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation
|
N/A |