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Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES (SMART-CHOICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079194
Recruitment Status : Unknown
Verified January 2019 by Hyeon-Cheol Gwon, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

Study Description
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Brief Summary:
To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: P2Y12 antagonist monotherapy Drug: aspirin plus P2Y12 antagonist Not Applicable

Detailed Description:
This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents
Actual Study Start Date : March 18, 2014
Actual Primary Completion Date : July 7, 2018
Estimated Study Completion Date : July 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: P2Y12 antagonist monotherapy
P2Y12 antagonist monotherapy after 3-month DAPT
 Drug: P2Y12 antagonist monotherapy
Experimental: Aspirin + P2Y12 antagonist
Aspirin + P2Y12 antagonist after 3-month DAPT
 Drug: aspirin plus P2Y12 antagonist


Outcome Measures
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Primary Outcome Measures :
  1. A composite of death, myocardial infarction, or cerebrovascular events [ Time Frame: 1 year ]
    12 months after the index procedure


Secondary Outcome Measures :
  1. All cause Death [ Time Frame: 1 years ]
  2. cardiac death [ Time Frame: 1 years ]
  3. Myocardial infarction (MI) [ Time Frame: 1 years ]
  4. Cerebrovascular accident (CVA) [ Time Frame: 1 years ]
  5. Target lesion revascularization (TLR) [ Time Frame: 1 years ]
  6. Target vessel revascularization (TVR) [ Time Frame: 1 years ]
  7. Any revascularization [ Time Frame: 1 years ]
  8. Stent thrombosis: definite or probable stent thrombosis by ARC definition [ Time Frame: 1 years ]
  9. BARC bleeding ≥2 [ Time Frame: 1 years ]
  10. BARC bleeding ≥3 [ Time Frame: 1 years ]
  11. Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization [ Time Frame: 1 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be at least 20 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • Patients undergoing successful PCI

Exclusion Criteria:

  • Hemodynamic instability or cardiogenic shock
  • Active bleeding
  • Known hypersensitivity or contraindication to study medications
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • DES implantation within 12 months before index procedure
Contacts and Locations
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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): NCT02079194


Locations
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Korea, Republic of
Cardiac and Vascular Center; Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02079194    
Other Study ID Numbers: SMC 2014-01-161
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Drug-eluting stents
aspirin
P2Y12 antagonist monotherapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics