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

Phase 4

Completed

• Conditions: Percutaneous Transluminal Coronary Angioplasty; Coronary Disease
• Interventions: Drug: aspirin and clopidogrel; Drug: Clopidogrel only

• Registration Number: NCT02939872
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Study Start: 2017-03-09
• Primary Completion: 2021-05-09
• Status Verified: 2024-06
• Study Completion: 2024-06-03
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAPT	aspirin and clopidogrel	Dual antiplatelet therapy : aspirin and clopidogrel
Clopidogrel only	Clopidogrel only	Clopidogrel monotherapy

Primary Outcome Measures

Name	Time	Method
composite event of death, myocardial infarction, or stroke	1 year

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization	5 years
Stent thrombosis	5 years
Bleeding	5 years
Death	5 years	all cause death or cardiac death
Myocardial Infarction	5 years
Stroke	5 years	cerebral ischemic or hemorrhage
Target Vessel Revascularization	5 years

Trial Locations

Locations (2)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of