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

Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Drug: aspirin and clopidogrel; Drug: Clopidogrel only

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men or women at least 19 years of age
2. Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS
3. Among the participants underwent PCI with BVS, event-free patients who survived the first 12 months without death, serious MI, stroke, repeat revascularization or major bleeding (except non-significant peri-procedural MI)
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Contraindication to antiplatelet therapy
2. If the physician believes that the patient need continuation of dual anti-platelet therapy because of comorbidities (ACS, peripheral vascular disease, significant carotid disease, etc.)
3. Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis)
4. Cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
5. Pregnancy test positive (hCG test is performed before randomization in all fertile women)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite event of death, myocardial infarction, or stroke	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis		5 years
Death	all cause death or cardiac death	5 years
Myocardial Infarction		5 years
Stroke	cerebral ischemic or hemorrhage	5 years
Target Vessel Revascularization		5 years
Target Lesion Revascularization		5 years
Bleeding		5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): May 9, 2021
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimated): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Bioresorbable Vascular Scaffold; BVS; Dual Antiplatelet Therapy; DAPT
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: AMCCV2016-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No