Clopidogrel versus Aspirin Monotherapy after Percutaneous Coronary Intervention and Standard Dual Antiplatelet Therapy in Patients at High Risk for Recurrent Ischemic Events
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005076
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5000
?over 19 years of age
?Patients with high risk of relapse of ischemic events who have been undergoing percutaneous coronary artery intervention using a drug-extraction stent for more than 12 months and undergoing double-anti-blood platelet treatment (if one or more of the following clinical or lesion characteristics are satisfied, patients with single treatment are excluded. Patients who have been receiving double anti-septic platelets for more than 12 months may be subject to study regardless of how long or 12 months have passed since the procedure.)
1)clinical characteristic
i)Treatment with myocardial infarction
ii)drug-treated diabetes
2)lesion characteristics: See coronary complex lesion features below
?a person who can voluntarily sign a consent form.
*Anatomical features of coronary complex lesions are defined as those accompanied by one or more of the following nine.
1) Medina classification (1,1/1,0,1/0,1,1) and the opening lesions of the lateral branch can be treated.
2) If the target vessel is a chronic completely occlusion lesion (=3 months)
3) In the case of unprotected left-wing paper lesions (left-wing journal lesions include non-true branch lesions.)
4) In case the inserted stent is longer than 38mm in length
5) Coronary artery intervention procedures are performed in two or more major coronary arteries at once due to polyvascular diseases.
6) If multiple stents are required (=3 more stent per patient)
7) In case of coronary stent re-stenosis lesion
8) Severe coronary calculus in angiography
9) In the case of left-hand lower limb, left-hand gland, and right-hand artery inlet lesions.
?In case of hypersensitivity to clinical trial drugs (aspirin or clopidogrel) or a taboo on medication,
?Patients requiring continuous anticoagulant treatment
?Patients who need to be treated with double anti-blood platelet due to arteriosclerotic diseases other than coronary artery diseases
?Patients scheduled to open a blood vessel in the coronary artery
?Patients undergoing single treatment
?Pregnant women and breastfeeding women
?Those who have a life expectancy of less than 2 years or are expected to be less compliant with treatment due to non-heart disease (medical judgment by the investigator)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACCE (major adverse cardiac and cerebrovascular events, a composite of all-cause death, MI, or stroke)
- Secondary Outcome Measures
Name Time Method All-cause death;Cardiac death;Myocardiac infarction;stroke;Stent thrombosis, definite or probable by Academic Research Consortium] definition;All-cause death or myocardial infarction;Cardiac death or myocardial infarction;Cardiac death, myocardial infarction, or stroke;Cardiac death, myocardial infarction, or stent thrombosis;Major bleeding (Bleeding Academic Research Consortium type 3 or 5);Minor and Major bleeding (Bleeding Academic Research Consortium type 2, 3 or 5);A composite of GI clinical events;Gastrointestinal ulcer or bleeding;gastroesophageal reflux disease, GERD;NACE (Net adverse clinical events, major adverse cardiac and cerebrovascular events + Bleeding Academic Research Consortium type 3 or 5 bleeding);TLR, target-lesion revascularization;TVR, target-vessel revascularization;Any revascularization;medical cost