Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation

NCT ID: NCT01557075

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

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.

Conditions

Drug-eluting Stent (DES)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Atorvastatin group

Atorvastatin 40 mg daily for 12 months after randomization

Group Type: ACTIVE_COMPARATOR

Atorvastatin (High dose statin treatment)

Intervention Type: 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

• Atorvastatin 40 mg daily for 12 months after randomization

Pravastatin group

Pravastatin 20mg daily for 12 months after randomization

Group Type: ACTIVE_COMPARATOR

Pravastatin (High dose statin treatment)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

DES-statin

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Myeong-Ki Hong

Professor of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myeong-Ki Hong, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Hong Myeong-Ki

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myeong-Ki Hong, MD,PhD

Role: CONTACT

mkhong61@yuhs.ac

+82 2 2228 8458

Byeong-Keuk Kim, MD,PhD

Role: CONTACT

kimbk@yuhs.ac

+82 2 2228 8465

Facility Contacts

Myeong-Ki Hong, MD.PhD

Role: primary

mkhong61@yuhs.ac

+82 2 2228 8458

Byeong-Keuk Kim, MD.PhD

Role: backup

kimbk@yuhs.ac

+82 2 2228 8465

References

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.

Reference Type: DERIVED

PMID: 28716428 (View on PubMed)

Other Identifiers

4-2010-0298

Identifier Type: -

Identifier Source: org_study_id