Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation (statin)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Myeong-Ki Hong, Yonsei University
ClinicalTrials.gov Identifier:
NCT01557075
First received: March 12, 2012
Last updated: March 16, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • cardiac or non-cardiac death [ Time Frame: 12month ] [ Designated as safety issue: No ]
    1. Major determinant for the occurrence of major events(death,MI,TVR,ST)
    2. Comparisons of the occurrence of major events according to the attainment of recommended LDL-C goal on current lipid guideline
    3. Association between laboratory test and clinical outcomes;
    4. Sub-study according to the subsets of disease
    5. 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

  • Atorvastatin 40 mg daily for 12 months after randomization
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
Criteria

Inclusion Criteria:

  1. Patients who had previously received DES at least 12 months(±2month) ago
  2. Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
  3. Patients with mono antiplatelet therapy with only aspirin after
  4. Age 20 years of older
  5. Patients with signed informed consent

Exclusion Criteria:

  1. History of DES or BMS implantation within 10 months
  2. 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
  3. Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
  4. Pregnant women or women with potential childbearing
  5. Life expectancy ≤ 2 year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557075

Contacts
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

Locations
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         
Sponsors and Collaborators
Yonsei University
Investigators
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014