Overview

Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)

Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Clopidogrel
Prasugrel Hydrochloride
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

1. Subject must be ≥ 20 years.

2. 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.

3. Subject must have a culprit lesion in a native coronary artery with significant
stenosis (>50% by visual estimate) eligible for stent implantation.

4. 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.

5. Target lesion(s) must be located in a native coronary artery with visually estimated
diameter of ≥ 2.25 mm and ≤ 4.25 mm.

6. Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria:

1. 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.)

2. Patients with active pathologic bleeding

3. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery
within 2 months.

4. Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months.

5. Female of childbearing potential, unless a recent pregnancy test is negative, who
possibly plan to become pregnant any time after enrollment into this study.

6. History of bleeding diathesis, known coagulopathy (including heparin-induced
thrombocytopenia), or will refuse blood transfusions

7. Noncardiac comorbid conditions are present with life expectancy <1 year or that may
result in protocol noncompliance (per site investigator's medical judgment).

8. An elective surgical procedure is planned that would necessitate interruption of
clopidogrel during the first 12 months post enrollment.

9. Patients who are actively participating in another drug or device investigational
study, which have not completed the primary endpoint follow-up period.