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Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events (BVS LATE)

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ClinicalTrials.gov Identifier: NCT02939872
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
The purpose of this study is to evaluate optimal duration of antiplatelet therapy after Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic events.

Condition or disease Intervention/treatment Phase
Percutaneous Transluminal Coronary Angioplasty Coronary Disease Drug: aspirin and clopidogrel Drug: Clopidogrel only Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DAPT
Dual antiplatelet therapy : aspirin and clopidogrel
Drug: aspirin and clopidogrel
at the discretion of investigator

Active Comparator: Clopidogrel only
Clopidogrel monotherapy
Drug: Clopidogrel only
at the discretion of investigator




Primary Outcome Measures :
  1. composite event of death, myocardial infarction, or stroke [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 5 years ]
    all cause death or cardiac death

  2. Myocardial Infarction [ Time Frame: 5 years ]
  3. Stroke [ Time Frame: 5 years ]
    cerebral ischemic or hemorrhage

  4. Target Vessel Revascularization [ Time Frame: 5 years ]
  5. Target Lesion Revascularization [ Time Frame: 5 years ]
  6. Stent thrombosis [ Time Frame: 5 years ]
  7. Bleeding [ Time Frame: 5 years ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 and more
  • On dual or triple antiplatelet therapy and between 12months and 14months from Bioresorbable Vascular Scaffold implantation
  • No history of death, serious myocardial infarction, stroke, repeat revascularization, or major bleeding

Exclusion Criteria:

  • Contraindication to antiplatelet therapy
  • Need to continue clopidogrel due to stroke, peripheral disease, significant carotid disease or recent acute coronary syndrome
  • Major bleeding history or bleeding diathesis
  • Pregnancy

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): NCT02939872


Contacts
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Contact: Seung-jung Park, MD +82230104812 sjpark@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-Jung Park, MD         
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD       kks7379@cu.ac.kr   
Principal Investigator: Kee-Sik Kim, MD         
Keimyung University Dongsan Medical Center Withdrawn
Daegu, Korea, Republic of
Gangneung Asan Hospital Not yet recruiting
Gangneung, Korea, Republic of
Contact: Sang-yong Yoo, MD       bovio@naver.com   
Principal Investigator: Sang-yong Yoo, MD         
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Contact: Young-Keun Ahn, MD       cecilyk@chonnam.ac.kr   
Principal Investigator: Young-Keun Ahn, MD         
Gachon University Gil Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Tae-Hoon Ahn, MD       encore@gilhospital.com   
Principal Investigator: Tae-Hoon Ahn, MD         
Dong-A Medical Center Not yet recruiting
Pusan, Korea, Republic of
Contact: Moo-Hyun Kim, MD       kmh60@damc.or.kr   
Principal Investigator: Moo-Hyun Kim, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Seung-Un Na, MD       swrha617@yahoo.co.kr   
Principal Investigator: Seung-Un Na, MD         
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Yang-soo Jang, MD       jangys1212@yuhs.ac   
Principal Investigator: Yang-soo Jang, MD         
Bundang CHA Hospital Not yet recruiting
Sungnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

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Responsible Party: Seung-Jung Park, professor, Division of Cardiology, Department of Internal Medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02939872     History of Changes
Other Study ID Numbers: AMCCV2016-23
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seung-Jung Park, Asan Medical Center:
DAPT
BVS
Bioresorbable Vascular Scaffold
Dual Antiplatelet Therapy

Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Disease
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Clopidogrel
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents