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A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).
The study is prospectively conducted at 4 high-volume PCI center in China with OCT expertise. Angiographic follow-up and OCT imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents. OCT endpoints are: (1) Subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts. The study is powered for OCT endpoints, which are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 10%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Ticagrelor 90mg tablet, twice daily |
|
| Clopidogrel | Experimental | Clopidogrel 75mg tablet, daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Plain, round, yellow, filmcoated tablet, 90 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subclinical thrombus | The occurrence of subclinical thrombus as detected by OCT | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial coverage of the stent struts assessed by optical coherence tomography | 12 months | |
| Neointimal proliferation within the stent assessed by optical coherence tomography | 12 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaoliang Chen, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40064903 | Derived | Xu Y, Wang YF, Zhao MY, You W, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Yin DL, Zhan ME, Jia HB, Liu B, Ye F. Study on the potential clinical significance of subclinical stent edge effects after drug-eluting stent implantation. Sci Rep. 2025 Mar 10;15(1):8258. doi: 10.1038/s41598-024-81329-7. | |
| 38820294 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2024 | |
| Reset | Aug 21, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2024 | Aug 21, 2024 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Clopidogrel | Drug | Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves) |
|
|
| Stent malposition assessed by optical coherence tomography |
| 12 months |
| Edge dissections assessed by optical coherence tomography | 12 months |
| Nong JC, You W, Wang YF, Xu Y, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Jia HB, Yin DL, Li L, Ye F. Dynamic natural components and morphological changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome and mild chronic kidney disease at the 1-year follow-up and clinical significance at the 5-year follow-up. PLoS One. 2024 May 31;19(5):e0302547. doi: 10.1371/journal.pone.0302547. eCollection 2024. |
| 37005448 | Derived | Meng PN, Nong JC, Xu Y, You W, Xu T, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yin DL, Jia HB, Yang S, Ye F. Morphologies and composition changes in nonculprit subclinical atherosclerosis in diabetic versus nondiabetic patients with acute coronary syndrome who underwent long-term statin therapy. Sci Rep. 2023 Apr 1;13(1):5338. doi: 10.1038/s41598-023-32638-w. |
| 35939981 | Derived | Nong JC, You W, Xu T, Meng PN, Xu Y, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yang S, Yin DL, Ye F. Dynamic natural morphologies and component changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome at 1-year follow-up and clinical significance at 3-year follow-up. Atherosclerosis. 2022 Sep;356:1-8. doi: 10.1016/j.atherosclerosis.2022.07.013. Epub 2022 Jul 31. |
| 32326796 | Derived | Wu X, You W, Wu Z, Wu Q, Jiang J, Yan H, Ye F, Chen S. Ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug-eluting stent implantation-a multicenter and randomized study. Platelets. 2021 Apr 3;32(3):404-412. doi: 10.1080/09537104.2020.1754381. Epub 2020 Apr 24. |
| 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 |