Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation (statin)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug-eluting Stent (DES) |
Drug: Atorvastatin (High dose statin treatment) Drug: Pravastatin (High dose statin treatment) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study |
- the composite of death from any cause [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]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.
- cardiac or non-cardiac death [ Time Frame: 12month ] [ Designated as safety issue: No ]
- Major determinant for the occurrence of major events(death,MI,TVR,ST)
- Comparisons of the occurrence of major events according to the attainment of recommended LDL-C goal on current lipid guideline
- Association between laboratory test and clinical outcomes;
- Sub-study according to the subsets of disease
- Association between parameters at index procedure and clinical outcomes
| Estimated Enrollment: | 2000 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Atorvastatin group
Atorvastatin 40 mg daily for 12 months after randomization
|
Drug: Atorvastatin (High dose statin treatment)
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
Other Name: DES-statin
|
|
Active Comparator: Pravastatin group
Pravastatin 20mg daily for 12 months after randomization
|
Drug: Pravastatin (High dose statin treatment)
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 |
Detailed Description:
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
- Prospective, randomized, multi-center study of each 1000 subjects enrolled.
- Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
- Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who had previously received DES at least 12 months(±2month) ago
- Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
- Patients with mono antiplatelet therapy with only aspirin after
- Age 20 years of older
- Patients with signed informed consent
Exclusion Criteria:
- History of DES or BMS implantation within 10 months
- Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
- Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
- Pregnant women or women with potential childbearing
- Life expectancy ≤ 2 year
Contacts and Locations| Contact: Myeong-Ki Hong, MD,PhD | +82 2 2228 8458 | mkhong61@yuhs.ac |
| Contact: Byeong-Keuk Kim, MD,PhD | +82 2 2228 8465 | kimbk@yuhs.ac |
| Korea, Republic of | |
| Hong Myeong-Ki | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Myeong-Ki Hong, MD.PhD +82 2 2228 8458 mkhong61@yuhs.ac | |
| Contact: Byeong-Keuk Kim, MD.PhD +82 2 2228 8465 kimbk@yuhs.ac | |
| Principal Investigator: Myeong-Ki Hong, MD.PhD | |
| Principal Investigator: | Myeong-Ki Hong, MD.PhD. | Severance Hospital |
More Information
No publications provided
| Responsible Party: | Myeong-Ki Hong, Professor of cardiology, Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01557075 History of Changes |
| Other Study ID Numbers: | 4-2010-0298 |
| Study First Received: | March 12, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Yonsei University:
|
High dose statin |
Additional relevant MeSH terms:
|
Atorvastatin Pravastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013