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

Acute Coronary Syndrome Clinical Trial

— SMART-DATE  

Official title:

Smart Angioplasty Research Team: Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes (SMART-DATE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01701453
• Other study ID #: 2011-12-070
• Status: Active, not recruiting
• Phase: N/A
• First received: September 24, 2012
• Last updated: February 6, 2018
• Start date: August 2012
• Est. completion date: November 2019

Study information

• Verified date: February 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2712
• Est. completion date: November 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event	defined as MACCE	at 18-month after the index procedure
Secondary	All-cause mortality	Individual component of MACCE	at 18-month after the index procedure
Secondary	Spontaneous MI	Individual component of MACCE	at 18-month after the index procedure
Secondary	Cerebrovascular event	Individual component of MACCE	at 18-month after the index procedure
Secondary	Stent thrombosis	Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)	at 18-month after the index procedure
Secondary	Bleeding	Bleeding Academic Research Consortium (BARC) type 2 to 5	at 18-month after the index procedure