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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 7, 2013
Last verified: December 2013

September 24, 2012
December 7, 2013
August 2012
February 2016   (final data collection date for primary outcome measure)
Composite of death, spontaneous myocardial infarction [MI], cerebrovascular event, stent thrombosis, or BARC Type 3, 4 and 5 bleeding [ Time Frame: over the 6- to 18-month postindex 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 new 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.
  1. Primary endpoint composite of death, spontaneous MI, stent thrombosis, cerebrovascular events or BARC Type 3, 4 and 5 bleeding over the 6- to 18-month for comparison of 6-month vs. 12-month or longer clopidogrel treatment
  2. Secondary endpoint 1) 6- to 18-month each component of primary endpoint 2) 6- to 18-month death, or myocardial infarction (MI) 3) 6- to 18-month cardiac death 4) 6- to 18-month target vessel failure (TVF) : cardiac death, MI in the target vessel territory, target vessel revascularization (TVR) 5) 6- to 18-month major adverse cardiac and cerebrovascular events (all death, MI, cerebrovascular event, revascularization [MACCE]) 6) 6- to 36-month death, MI, cerebrovascular events, stent thrombosis or BARC Type 3, 4 and 5 bleeding 7) 6- to 60-month death, MI, cerebrovascular events, stent thrombosis or BARC Type 3, 4 and 5 bleeding
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: clopidogrel
  • Experimental: 6 months group
    6months duration clopidogrel treatment
    Intervention: Drug: clopidogrel
  • Experimental: 12 months or longer group
    12 months or longer duration clopidogrel treatment
    Intervention: Drug: clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject must be at least 20 years of age.
  2. Subject must have evidence of acute coronary syndrome (e.g., unstable angina, NSTEMI, or STEMI)
  3. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving 6-month or 12-month or longer duration of DAPT and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

  1. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment.
  2. Patients with cardiogenic shock
  3. Subjects who have dialysis.
  4. Women who are pregnant or breast feeing
  5. Less than 2years life expectancy by previous medical history
  6. Patients with hypersensitivity or contraindications for aspirin or clopidogrel
  7. Patients who need long-tem clopidogrel taking due to cerebral infarction or other diseases
  8. Patients who can not give written consent such as mental illness
Both
20 Years and older
No
Contact: Hyeon-Cheol Gwon, PhD 82-2-3410-3418 hcgwon@skku.edu
Contact: Young Bin Song, MD 82-2-3410-3419 youngbin.song@gmail.com
Korea, Republic of
 
NCT01701453
2011-12-070
Yes
Hyeon-Cheol Gwon, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyeon-Cheol Gwon, PhD Samsung Medical Center
Samsung Medical Center
December 2013

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