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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental |
| |
| Clopidogrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 180mg loading and 90mg bid |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first occurrence of any bleeding event | Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings) | 1year |
| The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first occurrence of major bleeding event | by PLAtelet inhibition and patient Outcomes(PLATO) criteria | 1year |
| The time to first occurrence of minor bleeding event | by PLAtelet inhibition and patient Outcomes(PLATO) criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea | ||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37757520 | Derived | Jang MH, Kim AR, Kim T, Oh HJ, Lee JH, Lee YJ, Kim S, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; TICAKOREA Investigators. Age- and Sex-Specific Disparities in Outcomes After Ticagrelor Versus Clopidogrel in East Asian Patients. Am J Cardiol. 2023 Nov 15;207:237-244. doi: 10.1016/j.amjcard.2023.08.124. Epub 2023 Sep 26. | |
| 37323862 |
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This is not a publicly funded trial.
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| Drug |
600mg loading and 75mg qd |
|
| 1year |
| The time to first occurrence of major bleeding event or minor bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year |
| The time to first occurrence of major bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year |
| The time to first occurrence of minor bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year |
| The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5 | By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events | 1year |
| The time of first occurrence of discontinuation of study medication from any bleeding event | 1year |
| Non serious adverse events | 1year |
| Adverse events following discontinuation of study medication | 1year |
| Serious adverse events | 1year |
| The time to first occurrence of death from vascular causes | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes | 1year |
| The time to first occurrence of myocardial infarction | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction | 1year |
| The time to first occurrence of stroke | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke | 1year |
| The time to occurrence of composite events | The time to occurrence of composite events(death from any cause, myocardial infarction, stroke) | 1year |
| The time to occurrence of death from any cause | 1year |
| Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke. | 1year |
| Daegu |
| South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Dongguk University Gyeongju Hospital | Gyeongju | South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| ChonBuk National University Hospital | Jeonju | South Korea |
| Dong-A Medical Center | Pusan | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Lee J, Kim MJ, Kim M, Park J, Kim H, Cho S, Choi Y, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park SJ, Park DW; TICAKOREA Study Investigators. Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients. JACC Asia. 2023 Feb 7;3(3):390-399. doi: 10.1016/j.jacasi.2022.11.012. eCollection 2023 Jun. |
| 36444315 | Derived | Choi Y, Kang DY, Lee J, Lee J, Kim M, Kim H, Park J, Cho S, Lee J, Cha SJ, Kim TO, Lee PH, Ahn JM, Park SJ, Park DW; TICA KOREA Investigators. Ticagrelor Versus Clopidogrel in East Asian Patients With Acute Coronary Syndrome and Diabetes Mellitus. JACC Asia. 2022 Nov 15;2(6):666-674. doi: 10.1016/j.jacasi.2022.07.005. eCollection 2022 Nov. |
| 31553203 | Derived | Park DW, Kwon O, Jang JS, Yun SC, Park H, Kang DY, Ahn JM, Lee PH, Lee SW, Park SW, Choi SW, Lee SG, Yoon HJ, Ahn T, Kim MH, Nah DY, Lee SY, Chae JK, Park SJ; TICAKOREA Investigators. Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1865-1877. doi: 10.1161/CIRCULATIONAHA.119.041766. Epub 2019 Sep 25. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000787 | Angina Pectoris |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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