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

NCT ID: NCT02939872

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2024-06-03

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.

Conditions

Percutaneous Transluminal Coronary Angioplasty; Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAPT

Dual antiplatelet therapy : aspirin and clopidogrel

Group Type: EXPERIMENTAL

aspirin and clopidogrel

Intervention Type: DRUG

at the discretion of investigator

Clopidogrel only

Clopidogrel monotherapy

Group Type: ACTIVE_COMPARATOR

Clopidogrel only

Intervention Type: DRUG

at the discretion of investigator

Interventions

aspirin and clopidogrel

at the discretion of investigator

Intervention Type: DRUG

Clopidogrel only

at the discretion of investigator

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

professor, Division of Cardiology, Department of Internal Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Countries

South Korea

Other Identifiers

AMCCV2016-23

Identifier Type: -

Identifier Source: org_study_id