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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01701453
First received: September 24, 2012
Last updated: July 12, 2016
Last verified: July 2016

September 24, 2012
July 12, 2016
August 2012
August 2016   (final data collection date for primary outcome measure)
Composite of death, spontaneous myocardial infarction [MI], cerebrovascular event [ Time Frame: at 18-month after index hospitalization ] [ Designated as safety issue: Yes ]
Composite of death, myocardial infarction [MI], cerebrovascular event, stent thrombosis, or PLATO major bleeding [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01701453 on ClinicalTrials.gov Archive Site
  • Any cause of death [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Any cause of death or spontaneous MI [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Any cause of death, MI, cerebrovascular events, stent thrombosis or BARC Type 3, 4 and 5 bleeding [ Time Frame: over the 6- to 36-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Any cause of death, MI, cerebrovascular events, stent thrombosis or BARC Type 3, 4 and 5 bleeding [ Time Frame: over the 6- to 60-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Cerebrovascular event [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • BARC Type 3, 4 and 5 bleeding [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • death [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • death or MI [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • death, MI, cerebrovascular events, stent thrombosis or PLATO major bleeding [ Time Frame: over the 6- to 36-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • death, MI, cerebrovascular events, stent thrombosis or PLATO major bleeding [ Time Frame: over the 6- to 60-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • Cerebrovascular event [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]
  • PLATO major bleeding [ Time Frame: over the 6- to 18-month postindex hospitalization ] [ Designated as safety issue: Yes ]

    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 DAPT compared to conventional 12-month-or-longer duration after second-generation DES implantation in patients with acute coronary syndrome.
  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 component of primary endpoint at 18-month after index procedure Death, or myocardial infarction (MI) at 18-month after index procedure Cardiac death at 18-month after index procedure Target vessel failure (TVF) : cardiac death, MI in the target vessel territory, target vessel revascularization (TVR) at 18-month after index procedure Major adverse cardiac and cerebrovascular events (all death, MI, cerebrovascular event, revascularization [MACCE]) at 18-month after index procedure Death, MI, cerebrovascular events, stent thrombosis or BARC Type 2, 3, 4, and 5 at 18-month after index procedure Death, MI, cerebrovascular events, stent thrombosis or BARC Type 2, 3, 4, and 5 at 18-month after index procedure
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
  • Experimental: 6 months group
    6months duration P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
    Intervention: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
  • Experimental: 12 months or longer group
    12 months or longer duration P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
    Intervention: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2700
August 2019
August 2016   (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 acute coronary syndrome that includes unstable angina and myocardial infarction. The specific definitions of acute coronary syndrome, as follows; 1) ST-segment elevation MI (STEMI)

    • elevation of ST-segment more than 0.1 mV in 2 or more contiguous 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

      1. Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia
      2. 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.28

  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. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (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.
Both
20 Years and older   (Adult, Senior)
No
Contact: Hyeon-Cheol Gwon, MD, PhD 82-2-3410-3418 hcgwon@skku.edu
Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-3849 jyhahn@skku.edu
Korea, Republic of
 
NCT01701453
2011-12-070
Yes
Yes
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
July 2016

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