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
  Purpose
  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

Condition Intervention
Acute Coronary Syndrome
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Composite of death, spontaneous myocardial infarction [MI], cerebrovascular event [ Time Frame: at 18-month after index hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2700
Study Start Date: August 2012
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 months group
6months duration 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 P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) treatment
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
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 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
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701453

Contacts
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

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyoen-Cheol Gwon, PhD    82-2-3410-3418    hcgwon@skku.edu   
Principal Investigator: Hyoen-Cheol Gwon, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyeon-Cheol Gwon, MD, PhD    82-2-3410-3418    hc.gwon@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
  More Information

Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01701453     History of Changes
Other Study ID Numbers: 2011-12-070 
Study First Received: September 24, 2012
Last Updated: July 12, 2016
Health Authority: South Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript

Keywords provided by 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

ClinicalTrials.gov processed this record on July 26, 2016