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The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design.
Objective: To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin group | Active Comparator | Atorvastatin 40 mg daily for 12 months after randomization |
|
| Pravastatin group | Active Comparator | Pravastatin 20mg daily for 12 months after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin (High dose statin treatment) | Drug | Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
|
| Measure | Description | Time Frame |
|---|---|---|
| the composite of death from any cause | Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy. | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac or non-cardiac death |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeong-Ki Hong, MD,PhD | Contact | +82 2 2228 8458 | mkhong61@yuhs.ac | |
| Byeong-Keuk Kim, MD,PhD | Contact | +82 2 2228 8465 | kimbk@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Myeong-Ki Hong, MD.PhD. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Myeong-Ki | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28716428 | Derived | Im E, Cho YH, Suh Y, Cho DK, Her AY, Kim YH, Lee K, Kang WC, Yun KH, Yoo SY, Cheong SS, Shin DH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):423-431. doi: 10.1016/j.rec.2017.06.008. Epub 2017 Jul 14. English, Spanish. |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Pravastatin (High dose statin treatment) | Drug | Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Pravastatin 20mg daily for 12 months after randomization |
|
| 12month |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |