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

Coronary Disease Clinical Trial

— BVS LATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02939872
• Other study ID #: AMCCV2016-23
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 9, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: June 30, 2024
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Disease
• Percutaneous Transluminal Coronary Angioplasty

Intervention

Drug:
• aspirin and clopidogrel
at the discretion of investigator
• Clopidogrel only
at the discretion of investigator

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite event of death, myocardial infarction, or stroke		1 year
Secondary	Death	all cause death or cardiac death	5 years
Secondary	Myocardial Infarction		5 years
Secondary	Stroke	cerebral ischemic or hemorrhage	5 years
Secondary	Target Vessel Revascularization		5 years
Secondary	Target Lesion Revascularization		5 years
Secondary	Stent thrombosis		5 years
Secondary	Bleeding		5 years