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

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ClinicalTrials.gov Identifier: NCT01701453
Recruitment Status : Active, not recruiting
First Posted : October 5, 2012
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

September 24, 2012
October 5, 2012
February 8, 2018
August 2012
November 2017   (Final data collection date for primary outcome measure)
A composite of all-cause mortality, spontaneous myocardial infarction (MI), and cerebrovascular event [ Time Frame: at 18-month after the index procedure ]
defined as MACCE
Composite of death, myocardial infarction [MI], cerebrovascular event, stent thrombosis, or PLATO major bleeding [ Time Frame: over the 6- to 18-month postindex hospitalization ]
Complete list of historical versions of study NCT01701453 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE
  • Spontaneous MI [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE
  • Cerebrovascular event [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE
  • Stent thrombosis [ Time Frame: at 18-month after the index procedure ]
    Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)
  • Bleeding [ Time Frame: at 18-month after the index procedure ]
    Bleeding Academic Research Consortium (BARC) type 2 to 5
  • death [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • death or MI [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • Cardiac death [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • Target vessel failure defined as cardiac death, MI in the target vessel territory, target vessel revascularization (TVR) [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • Major adverse cardiac and cerebrovascular events [MACCE] defined as all death, MI, cerebrovascular event, any revascularization [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • death, MI, cerebrovascular events, stent thrombosis or PLATO major bleeding [ Time Frame: over the 6- to 36-month postindex hospitalization ]
  • death, MI, cerebrovascular events, stent thrombosis or PLATO major bleeding [ Time Frame: over the 6- to 60-month postindex hospitalization ]
  • myocardial infarction [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • Cerebrovascular event [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • Stent thrombosis [ Time Frame: over the 6- to 18-month postindex hospitalization ]
  • PLATO major bleeding [ Time Frame: over the 6- to 18-month postindex hospitalization ]

    PLATO major bleeding

    • Major bleed-life threatening :Fatal or intracranial or intrapericardial with cardiac tamponade or hypovolemic shock or severe hypotension requiring pressors of surgery
    • Major bleed-other; meets any of these criteria :Significantly disabling (eg, intraocular with permanent vision loss)
    • Minor bleed : Requires medical intervention to stop or treat bleeding
    • Minimal bleed : All others not requiring intervention or treatment
Not Provided
Not Provided
 
Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)
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)
  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.
  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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
  • Experimental: 6 months group
    6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
    Intervention: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
  • Experimental: 12 months or longer group
    12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
    Intervention: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Hahn JY, Song YB, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Kim J, Choi KH, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC; SMART-DATE investigators. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial. Lancet. 2018 Mar 31;391(10127):1274-1284. doi: 10.1016/S0140-6736(18)30493-8. Epub 2018 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2712
3000
November 2019
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01701453
2011-12-070
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript
Hyeon-Cheol Gwon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
Samsung Medical Center
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP