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

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 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.

Study Overview

• Status: Unknown
• Conditions: Drug-eluting Stent (DES)
• Intervention / Treatment: Drug: Atorvastatin (High dose statin treatment); Drug: Pravastatin (High dose statin treatment)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Myeong-Ki Hong, MD,PhD; Phone Number: +82 2 2228 8458; Email: mkhong61@yuhs.ac
• Study Contact Backup: Name: Byeong-Keuk Kim, MD,PhD; Phone Number: +82 2 2228 8465; Email: kimbk@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hong Myeong-Ki
    • Contact: Myeong-Ki Hong, MD.PhD; Phone Number: +82 2 2228 8458; Email: mkhong61@yuhs.ac
    • Principal Investigator: Myeong-Ki Hong, MD.PhD
    • Contact: Byeong-Keuk Kim, MD.PhD; Phone Number: +82 2 2228 8465; Email: kimbk@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac or non-cardiac death	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	12month

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Myeong-Ki Hong, MD.PhD., Severance Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: High dose statin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Atorvastatin; Pravastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: 4-2010-0298