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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

Brief 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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2012
Primary Completion Date : November 2017
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 6 months group
6 months duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Experimental: 12 months or longer group
12 months or longer duration of P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE

  2. Spontaneous MI [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE

  3. Cerebrovascular event [ Time Frame: at 18-month after the index procedure ]
    Individual component of MACCE

  4. Stent thrombosis [ Time Frame: at 18-month after the index procedure ]
    Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)

  5. Bleeding [ Time Frame: at 18-month after the index procedure ]
    Bleeding Academic Research Consortium (BARC) type 2 to 5



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701453


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01701453     History of Changes
Other Study ID Numbers: 2011-12-070
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
duration of DAPT

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Prasugrel Hydrochloride
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors