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 : Active, not recruiting

First Posted : October 20, 2016

Last Update Posted : June 23, 2021

Sponsor:

Collaborator:

CardioVascular Research Foundation, Korea

Information provided by (Responsible Party):

Seung-Jung Park, Asan Medical Center

Study Description

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

Study Design

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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
Actual Primary Completion Date :	May 9, 2021
Estimated Study Completion Date :	June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin Clopidogrel Clopidogrel bisulfate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Death [ Time Frame: 5 years ]
all cause death or cardiac death
Myocardial Infarction [ Time Frame: 5 years ]
Stroke [ Time Frame: 5 years ]
cerebral ischemic or hemorrhage
Target Vessel Revascularization [ Time Frame: 5 years ]
Target Lesion Revascularization [ Time Frame: 5 years ]
Stent thrombosis [ Time Frame: 5 years ]
Bleeding [ Time Frame: 5 years ]

Eligibility Criteria

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

Contacts and Locations

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

More Information

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Responsible Party:	Seung-Jung Park, professor, Division of Cardiology, Department of Internal Medicine, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT02939872
Other Study ID Numbers:	AMCCV2016-23
First Posted:	October 20, 2016 Key Record Dates
Last Update Posted:	June 23, 2021
Last Verified:	June 2021
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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Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular 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

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