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A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BioFreedom with 1 month DAPT

BioMatrix or Ultimaster with 6 to 12 months DAPT

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients ≥ 19 years old
Patients with ischemic heart disease who are considered for coronary revascularization with PCI
Significant coronary de novo lesion

Exclusion Criteria:

Acute myocardial infarction
Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion
Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions
Cardiogenic shock or experience of cardiopulmonary resuscitation
Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media
History of documented prior cerebrovascular attack within 6 months
Treated with any stent within 3 months
Reference vessel diameter <2.25 mm or >4.0 mm
Pregnant women or women with potential childbearing
Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Inability to understand or read the informed content

Sites / Locations

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short-term DAPT after Biofreedom

Long-term DAPT after BioMatrix or Ultimaster

Arm Description

Outcomes

Primary Outcome Measures

Composite of major adverse cardiovascular events

events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident

Secondary Outcome Measures

Full Information

NCT ID

NCT02513810

First Posted

July 31, 2015

Last Updated

March 2, 2020

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02513810

Brief Title

A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2, 2015 (Actual)

Primary Completion Date

September 17, 2019 (Actual)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Short-term DAPT after Biofreedom

Arm Type

Experimental

Arm Title

Long-term DAPT after BioMatrix or Ultimaster

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

BioFreedom with 1 month DAPT

Intervention Description

The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month.

Intervention Type

Device

Intervention Name(s)

BioMatrix or Ultimaster with 6 to 12 months DAPT

Intervention Description

Primary Outcome Measure Information:

Title

Composite of major adverse cardiovascular events

Description

events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients ≥ 19 years old Patients with ischemic heart disease who are considered for coronary revascularization with PCI Significant coronary de novo lesion Exclusion Criteria: Acute myocardial infarction Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesion Need to use of dual antiplatelet therapy more than 1 month because of other medical conditions Cardiogenic shock or experience of cardiopulmonary resuscitation Contraindication or hypersensitivity to Biolimus A9, stainless steel, heparin, antiplatelet agents or contrast media History of documented prior cerebrovascular attack within 6 months Treated with any stent within 3 months Reference vessel diameter <2.25 mm or >4.0 mm Pregnant women or women with potential childbearing Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Inability to understand or read the informed content

Facility Information:

Facility Name

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

35470799

Citation

Lee YJ, Cho JY, Yun KH, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial. EuroIntervention. 2022 Aug 19;18(6):471-481. doi: 10.4244/EIJ-D-22-00135.

Results Reference

derived

PubMed Identifier

34332946

Citation

Hong SJ, Kim JS, Hong SJ, Lim DS, Lee SY, Yun KH, Park JK, Kang WC, Kim YH, Yoon HJ, Won H, Nam CM, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; One-Month DAPT Investigators. 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1801-1811. doi: 10.1016/j.jcin.2021.06.003. Epub 2021 Jul 28.

Results Reference

derived

Learn more about this trial

A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-eluting Stent Implantation

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