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Trial record 86 of 292 for:    ASPIRIN AND clopidogrel AND dual

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

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: NCT02939872
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : June 25, 2019
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)
Actual Enrollment : 238 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 : May 9, 2021
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 ]


Information from the National Library of Medicine

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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


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Chonnam National University Hospital
Gwangju, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
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: June 25, 2019
Last Verified: June 2019
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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Aspirin
Clopidogrel
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
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