A randomized comparison of CLOpidogrel monotherapy versus extended dual-antiplatelet therapy beyond 12 months after implantation of drug-eluting StEnts in high-risk lesions or patients; A-CLOSE trial
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 3200
Inclusion criteria (must all met)
1. Patients >19 years old
2. Patients who underwent DES implantation 12 months (±5 months) previously.
3. High risk characteristics (clinical or lesion) for ischemic events (must at least one)
High risk patients; clinical criteria
(1) Acute coronary syndrome
(2) Previous history of cerebrovascular accidents
(3) History of peripheral artery intervention
(4) Heart failure (left ventricular ejection fraction =40%)
(5) Diabetes treated with medication
(6) Chronic renal insufficiency including end-stage renal diseases
High risk lesions; angiographic or procedural criteria
(1) Left main diseases
(2) Bifurcation lesions
(3) Chronic total occlusion
(4) In-stent restenotic lesions
(5) Graft lesions
(6) Diffuse long lesions requiring total stent length =28 mm
(7) Calcified lesions requiring atherectomy
(8) Multivessel coronary artery disease with multiple stents
(9) Small vessel disease requiring stent diameter of =2.5 mm
1. Age> 80 years
2. Pregnant women or women with potential childbearing
3. Life expectancy < 1 year
4. Refusal or inability to understand of informed consent
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method et clinical adverse event [NACE]
- Secondary Outcome Measures
Name Time Method Each components of NACE;All-cause or cardiovascular mortality;Major or minor bleeding;Major adverse cardiac event;Major Adverse Cardiac and Cerebrovascular Event