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 October 2014 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: October 19, 2014
Last verified: October 2014
  Purpose
  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.

Condition Intervention
Acute Coronary Syndrome
Drug: clopidogrel

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, 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 ]

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: 3000
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 months group
6months duration clopidogrel treatment
Drug: clopidogrel
Experimental: 12 months or longer group
12 months or longer duration clopidogrel treatment
Drug: clopidogrel

Detailed Description:
  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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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, PhD 82-2-3410-3418 hcgwon@skku.edu
Contact: Young Bin Song, MD 82-2-3410-3419 youngbin.song@gmail.com

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, PhD Samsung Medical Center
  More Information

No publications provided

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: October 19, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
duration of DAPT

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014