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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Biotronik SE & Co. KG | INDUSTRY |
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Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes, a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary syndrome patients on ASA background, have demonstrated superiority of ticagrelor over clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation. Several experimental and clinical studies support the hypothesis that adenosine could reduce cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there are no available data on coronary circulation effects after chronic treatment of ticagrelor in patients with ACS who have altered resting coronary blood flow dynamics due to advanced coronary artery disease.
This study is a prospective, randomized, open-label, active controlled study with two parallel study groups.
For inclusion in the study subjects should fulfill the following criteria:
To investigate the effects of ticagrelor on coronary microcirculation, IMR will be measured twice, 6 months apart in the same lesion, compared with clopidogrel.
The IMR is defined as simultaneously measured distal coronary pressure divided by the inverse of the thermodilution-derived hyperaemic mean transit time (Tmn), or more simply, distal coronary pressure multiplied by the Tmn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90mg, twice a day |
|
| Clopidogrel | Active Comparator | Clopidogrel 75mg, once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | 90mg, twice a day |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| Index of microcirculatory resistance using 0.014-in coronary pressure wire | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional flow reserve using 0.014-in coronary pressure wire | 6 months | |
| Coronary flow reserve using 0.014-in coronary pressure wire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyungil Park, MD | Dong-A University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine,Dong-A University College of Medicine | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34656119 | Derived | Moon H, Jo YS, Kim SJ, Jo S, Park K. Comparison of ticagrelor with clopidogrel on quality of life in patients with acute coronary syndrome. Health Qual Life Outcomes. 2021 Oct 16;19(1):242. doi: 10.1186/s12955-021-01875-w. | |
| 32028138 | Derived | Jeong YJ, Park K, Kim YD. Comparison between ticagrelor and clopidogrel on myocardial blood flow in patients with acute coronary syndrome, using 13 N-ammonia positron emission tomography. Am Heart J. 2020 Apr;222:121-130. doi: 10.1016/j.ahj.2020.01.013. Epub 2020 Jan 27. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2019 | |
| Reset | Dec 3, 2019 | |
| Release | Aug 22, 2020 | |
| Reset | Sep 8, 2020 | |
| Release | Apr 1, 2025 | |
| Reset | Apr 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2019 | Dec 3, 2019 | |||
| Aug 22, 2020 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular 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 |
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| Drug |
75mg, once a day |
|
| 31554423 | Derived | Park K, Cho YR, Park JS, Park TH, Kim MH, Kim YD. Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices. Circ Cardiovasc Interv. 2019 Oct;12(10):e008105. doi: 10.1161/CIRCINTERVENTIONS.119.008105. Epub 2019 Sep 26. |
| Sep 8, 2020 |
| Apr 1, 2025 | Apr 17, 2025 |
| 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 |