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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored arm | Experimental | 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 |
|
| Conventional arm | Active Comparator | clopidogrel + aspirin for 12months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored antithrombotic strategy | Drug | Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net clinical outcome | a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months after randomisation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death | 1 year |
| Myocardial infarction | Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction |
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Inclusion Criteria:
Age 19 and more
Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Exclusion Criteria:
Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
Use of Gp IIb/IIIa inhibitors at randomization
Cardiogenic shock
Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
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)
History of intracranial hemorrhage or intracranial aneurysm
Planned surgery within 180 days
Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL
At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
Use of 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
Pregnant and/or lactating women.
Concurrent medical condition with a life expectancy of less than 1 years
Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
Inability to provide written informed consent or participate in long-term follow-up
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Soon Chun Hyang University Hospital Bucheon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40886179 | Derived | Kang DY, Wee SB, Ahn JM, Park H, Yun SC, Park KH, Kang SH, Suh J, Bae JW, Park S, Cho JH, Suh JW, Lee BK, Rha SW, Won H, Jang JS, Cho YR, Lee CH, Ahn YK, Oh JH, Bae JS, Park CS, Lee JB, Choi J, Lee SW, Her SH, Kwon O, Park SJ, Park DW. Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary intervention: the TAILORED-CHIP randomized clinical trial. Eur Heart J. 2026 May 5;47(17):2044-2055. doi: 10.1093/eurheartj/ehaf652. | |
| 39492701 |
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| Conventional antithrombotic strategy | Drug | Clopidogrel + aspirin for 12months |
|
| 1 year |
| Stroke | Efficacy outcomes: any, ischemic, or hemorrhagic Stroke | 1 year |
| Stent thrombosis | Efficacy outcomes | 1 year |
| The rate of unplanned urgent repeat revascularization | Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation | 1 year |
| Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization) | Efficacy outcomes | 1 year |
| Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke) | Efficacy outcomes | 1 year |
| BARC major bleeding (type 3 or 5 bleeding) | Safety outcomes: Bleeding Academic Research Consortium | 1 year |
| TIMI major or minor bleeding | Safety outcomes: Thrombolysis In Myocardial Infarction | 1 year |
| GUSTO moderate or severe bleeding | Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries | 1 year |
| ISTH major bleeding | Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention | 1 year |
| Any major or minor bleeding | Safety outcomes | 1 year |
| Bucheon-si |
| South Korea |
| Gyeongsang National University Changwon Hospital | Changwon | South Korea |
| Chungbuk National University Hospital | Cheonju | South Korea |
| Gangwon National Univ. Hospital | Chuncheon | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Dong-A Medical Center | Pusan | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Bundang CHA Hospital | Seongnam | South Korea |
| Seoul university Bundang hospital | Seongnam-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Chung-Ang University Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| The Catholic Univ. of Korea Eunpyeong St. Mary's hospital | Seoul | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital | Seoul | South Korea |
| St.Carollo Hospital | Suncheon | South Korea |
| The Catholic University of Korea, ST. Mary's Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Derived |
| Park H, Kang DY, Ahn JM, Yun SC, Park KH, Kang SH, Suh J, Bae JW, Park S, Cho JH, Suh JW, Lee BK, Rha SW, Won H, Jang JS, Kim MH, Lee CH, Ahn YK, Oh JH, Bae JS, Park CS, Choi J, Lee JB, Lee SW, Hur SH, Kwon O, Park SJ, Park DW, Tailored-Chip Trial Investigators OBOT. Temporal modulation (early escalation and late de-escalation) of antiplatelet therapy in patients undergoing complex high-risk PCI: rationale and design of the TAILORED-CHIP trial. EuroIntervention. 2024 Nov 4;20(21):e1355-e1362. doi: 10.4244/EIJ-D-24-00437. |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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