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| Name | Class |
|---|---|
| Boston Scientific Korea Co. Ltd | INDUSTRY |
| Dio | INDUSTRY |
| Terumo Corporation | INDUSTRY |
| Abbott |
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Study objectives
Study design :
Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients
About 3400 patients derived from a population of Korean patients with acute coronary syndrome receiving percutaneous coronary intervention will be enrolled in the present trial.
All patients will receive a loading dose of aspirin (300 mg) and prasugrel (60 mg bolus) will be administered. Sixty-mg-loading dose of prasugrel will be given regardless of pretreated antiplatelet agents (clopidogrel, ticagrelor, or cilostazol). However, in patients who already loaded with other antiplatelet agents (clopidigrel, ticagrelor, or cilostazol), reduced dose (30mg) or omission of prasugrel loading is acceptable. Following angiography, patients with significant diameter stenosis >50% of coronary artery or graft vessel by visual estimation that have documented myocardial ischemia or symptoms of angina, and have lesions that are eligible for coronary intervention without any exclusion criteria, will be randomized 1:1 to either receive either BS-DES or BD-DES group.
At 1-month clinical follow-up, patients eligible for antiplatelet comparison will be additionally randomized 1:1 to either receive the reduce dose of prasugrel (5 mg daily) or conventional dose (10 mg daily). The exclusion criteria (age ≥75 years, body weight <60 kg, or history of TIA or stroke) is classified as observational cohort. Post-PCI, dual antiplatelet therapy is recommended for at least 1 year. Follow-up data will be collected until 3-year after index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BS-DES with prasugrel 10mg daily | Active Comparator | BS-DES with prasugrel 10mg daily |
|
| BS-DES with prasugrel 5mg daily | Active Comparator | BS-DES with prasugrel 5mg daily |
|
| BD-DES with prasugrel 10mg daily | Experimental | BD-DES with prasugrel 10mg daily |
|
| BD-DES with prasugrel 5mg daily | Experimental | BD-DES with prasugrel 5mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BS-DES (Biostable polymer drug-eluting stent) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization | 12months | |
| Antiplatelet arm : major adverse cardiovascular event (MACE), defined as a composite of all death, MI, stent thrombosis, repeat revascularization, CVA, and BARC class ≥2 bleeding | 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38887886 | Result | Kang J, Hwang D, Park KW, Han JK, Yang HM, Kang HJ, Koo BK, Lim YH, Rhew JY, Chun KJ, Lee BK, Kim S, Bae JW, Kim HS, Host Reduce Polytech Rct Trial Investigators OBOT. Durable-polymer versus biodegradable-polymer drug-eluting stents in acute coronary syndromes: three-year outcomes of the HOST REDUCE POLYTECH RCT Trial. EuroIntervention. 2024 Jun 17;20(12):e750-e759. doi: 10.4244/EIJ-D-23-01053. | |
| 36715152 |
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| INDUSTRY |
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| BD-DES (Biodegradable polymer drug-eluting stent) | Device |
|
|
| Prasugrel 5mg | Drug | Use prasugrel 5mg daily for maintaning dose |
|
|
| Derived |
| Lee KS, Park KH, Park KW, Rha SW, Hwang D, Kang J, Han JK, Yang HM, Kang HJ, Koo BK, Lee NH, Rhew JY, Chun KJ, Lim YH, Bong JM, Bae JW, Lee BK, Kim SY, Shin WY, Lim HS, Park K, Kim HS. Prasugrel dose de-escalation in diabetic patients with acute coronary syndrome receiving percutaneous coronary intervention: results from the HOST-REDUCE-POLYTECH-ACS trial. Eur Heart J Cardiovasc Pharmacother. 2023 Apr 10;9(3):262-270. doi: 10.1093/ehjcvp/pvad008. |
| 35262625 | Derived | Hwang D, Lim YH, Park KW, Chun KJ, Han JK, Yang HM, Kang HJ, Koo BK, Kang J, Cho YK, Hong SJ, Kim S, Jo SH, Kim YH, Kim W, Lee SY, Kim YD, Oh SK, Lee JH, Kim HS; HOST-RP-ACS investigators. Prasugrel Dose De-escalation Therapy After Complex Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: A Post Hoc Analysis From the HOST-REDUCE-POLYTECH-ACS Trial. JAMA Cardiol. 2022 Apr 1;7(4):418-426. doi: 10.1001/jamacardio.2022.0052. |
| 33205662 | Derived | Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Kim SY, Park KH, Rha SW, Shin WY, Lim HS, Park K, Park KW; HOST-REDUCE-POLYTECH-ACS Trial Investigators. Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial. Circulation. 2021 Mar 16;143(11):1081-1091. doi: 10.1161/CIRCULATIONAHA.120.051700. Epub 2020 Nov 18. |
| 32882163 | Derived | Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Rhew JY, Chun KJ, Lim YH, Bong JM, Bae JW, Lee BK, Park KW; HOST-REDUCE-POLYTECH-ACS investigators. Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial. Lancet. 2020 Oct 10;396(10257):1079-1089. doi: 10.1016/S0140-6736(20)31791-8. Epub 2020 Aug 31. |
| 26374625 | Derived | Lee JM, Jung JH, Park KW, Shin ES, Oh SK, Bae JW, Rhew JY, Lee N, Kim DB, Kim U, Han JK, Lee SE, Yang HM, Kang HJ, Koo BK, Kim S, Cho YK, Shin WY, Lim YH, Rha SW, Kim SY, Lee SY, Kim YD, Chae IH, Cha KS, Kim HS. Harmonizing Optimal Strategy for Treatment of coronary artery diseases--comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial. Trials. 2015 Sep 15;16:409. doi: 10.1186/s13063-015-0925-5. |
| 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 |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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