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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Drug-eluting Stent (DES)

Treatments: Drug: Pravastatin (High dose statin treatment); Drug: Atorvastatin (High dose statin treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT01557075

4-2010-0298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Atorvastatin group

Active Comparator group

Description:

Atorvastatin 40 mg daily for 12 months after randomization

Treatment:

Drug: Atorvastatin (High dose statin treatment)

Pravastatin group

Active Comparator group

Description:

Pravastatin 20mg daily for 12 months after randomization

Treatment:

Drug: Pravastatin (High dose statin treatment)