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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02513810

Collaborator

(none)

3,020

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: BioFreedom with 1 month DAPT Device: BioMatrix or Ultimaster with 6 to 12 months DAPT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3020 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Dec 2, 2015

Actual Primary Completion Date :

Sep 17, 2019

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Short-term DAPT after Biofreedom	Device: BioFreedom with 1 month DAPT 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.
Active Comparator: Long-term DAPT after BioMatrix or Ultimaster	Device: BioMatrix or Ultimaster with 6 to 12 months DAPT 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 the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist.

Arm

Intervention/Treatment

Experimental: Short-term DAPT after Biofreedom

Device: BioFreedom with 1 month DAPT

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.

Active Comparator: Long-term DAPT after BioMatrix or Ultimaster

Device: BioMatrix or Ultimaster with 6 to 12 months DAPT

Outcome Measures

Primary Outcome Measures

Composite of major adverse cardiovascular events [1 year]
events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02513810

Other Study ID Numbers:

1-2015-0040

First Posted:

Aug 3, 2015

Last Update Posted:

Mar 4, 2020

Last Verified:

Mar 1, 2020

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Mar 4, 2020