Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)
- Conditions
- Acute Coronary Syndrome
- Interventions
- Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
- Registration Number
- NCT01701453
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).
2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.
- Detailed Description
1. Primary endpoint
- MACCE, defined as a composite of all-cause mortality, myocardial infarction, and cerebrovascular events at 18 months after the index procedure.
2. Secondary endpoint
* Individual components of the primary endpoint at 18-month after the index procedure
* Definite/probable stent thrombosis, defined by the Academic Research Consortium (ARC) at 18-month after the index procedure.
* Bleeding complication, defined by Bleeding Academic Research Consortium (BARC) type 2 to 5 at 18-month after the index procedure.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2712
- Subject must be ≥ 20 years.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation.
- Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) : elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial necrosis (troponin or CK-MB > upper reference limit) with one of the following; (a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3) Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial.
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
- Patients with active pathologic bleeding
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
- Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
- An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12 months or longer group P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) 12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment 6 months group P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) 6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
- Primary Outcome Measures
Name Time Method A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event at 18-month after the index procedure defined as MACCE
- Secondary Outcome Measures
Name Time Method Stent thrombosis at 18-month after the index procedure Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)
Spontaneous MI at 18-month after the index procedure Individual component of MACCE
Cerebrovascular event at 18-month after the index procedure Individual component of MACCE
All-cause mortality at 18-month after the index procedure Individual component of MACCE
Bleeding at 18-month after the index procedure Bleeding Academic Research Consortium (BARC) type 2 to 5
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of