Clinical trial NCT01557075: Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug-eluting Stent (DES)
Keywords: High dose statin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the composite of death from any cause
timeFrame: 12 months after randomization
Secondary outcomes:
measure: cardiac or non-cardiac death
timeFrame: 12month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hong Myeong-Ki
Study officials:
affiliation: Severance Hospital
name: Myeong-Ki Hong, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.