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Primary endpoint
- MACCE, defined as a composite of all-cause mortality, myocardial infarction, and cerebrovascular events at 18 months after the index procedure.
Secondary endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 months group | Experimental | 6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment |
|
| 12 months or longer group | Experimental | 12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) | Drug | P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event | defined as MACCE | at 18-month after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Individual component of MACCE | at 18-month after the index procedure |
| Spontaneous MI | Individual component of MACCE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeon-Cheol Gwon, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34011436 | Derived | Song PS, Park YH, Oh JH, Song YB, Choi SH, Gwon HC, Cho DK, Rha SW, Bae JW, Jeong JO, Hahn JY; SMART-DATE and the SMART-CHOICE investigators. P2Y12 Inhibitor Monotherapy Versus Conventional Dual Antiplatelet Therapy or Aspirin Monotherapy in Acute Coronary Syndrome: A Pooled Analysis of the SMART-DATE and SMART-CHOICE Trials. Am J Cardiol. 2021 Jul 1;150:47-54. doi: 10.1016/j.amjcard.2021.03.053. Epub 2021 May 16. | |
| 33227548 |
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After publication of first manuscript
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| 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 |
|---|---|
| D000077144 | Clopidogrel |
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| at 18-month after the index procedure |
| Cerebrovascular event | Individual component of MACCE | at 18-month after the index procedure |
| Stent thrombosis | Definite or probable stent thrombosis defined by Academic Research Consortium (ARC) | at 18-month after the index procedure |
| Bleeding | Bleeding Academic Research Consortium (BARC) type 2 to 5 | at 18-month after the index procedure |
| Derived |
| Kedhi E, Delewi R, Fabris E, De Luca G, Hermanides RS, van den Ent M, Buszman P, Zijlstra F, Song YB, Gwon HC, Hahn JY. Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials. Atherosclerosis. 2020 Dec;315:55-61. doi: 10.1016/j.atherosclerosis.2020.11.003. Epub 2020 Nov 9. |
| 32354228 | Derived | Choi KH, Song YB, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Gwon HC, Hahn JY. Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial. Circ Cardiovasc Interv. 2020 May;13(5):e008530. doi: 10.1161/CIRCINTERVENTIONS.119.008530. Epub 2020 May 1. |
| 29544699 | Derived | Hahn JY, Song YB, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Kim J, Choi KH, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC; SMART-DATE investigators. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial. Lancet. 2018 Mar 31;391(10127):1274-1284. doi: 10.1016/S0140-6736(18)30493-8. Epub 2018 Mar 12. |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D010879 | Piperazines |