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

Purpose

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.
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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

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:	February 2016
Estimated Primary Completion Date:	February 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:

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
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:

Subject must be at least 20 years of age.
Subject must have evidence of acute coronary syndrome (e.g., unstable angina, NSTEMI, or STEMI)
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:

An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment.
Patients with cardiogenic shock
Subjects who have dialysis.
Women who are pregnant or breast feeing
Less than 2years life expectancy by previous medical history
Patients with hypersensitivity or contraindications for aspirin or clopidogrel
Patients who need long-tem clopidogrel taking due to cerebral infarction or other diseases
Patients who can not give written consent such as mental illness

Contacts and Locations

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:	February 11, 2013
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

duration of DAPT

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013