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3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI (BULK-STEMI)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ticagrelor monotherapy
Aspirin with P2Y12 receptor inhibitor
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ≥ 19 years old
  • Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
  • Provision of informed consent

Exclusion Criteria:

  • Age > 80 years
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year

Sites / Locations

  • Department of Internal Medicine,Dong-A University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor monotherapy

Aspirin with P2Y12 receptor inhibitor

Arm Description

Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)

Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)

Outcomes

Primary Outcome Measures

NACE: net clinical adverse event
The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)
Major adverse cardiac and cerebrovaascular event(MACCE)
Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis
Major bleeding (BARC type 3,5)
The number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). type 3a: Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding, type 3b: Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents, type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision, type 5a: Probable fatal bleeding, type 5b: Definite fatal bleeding (overt or autopsy or imaging confirmation in accordance with BARC Definitions

Secondary Outcome Measures

Individual component of MACCE and bleeding episode
All-cause mortality :Individual component of MACCE Acute MI :Individual component of MACCE Cerebrovascular event :Individual component of MACCE Stent thrombosis :Definite or probable stent thrombosis defined by Academic Research Consortium (ARC) Bleeding :Bleeding Academic Research Consortium (BARC) type 3 or 5

Full Information

First Posted
September 25, 2020
Last Updated
December 18, 2020
Sponsor
Dong-A University
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1. Study Identification

Unique Protocol Identification Number
NCT04570345
Brief Title
3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI
Acronym
BULK-STEMI
Official Title
3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the clinical outcomes of dual antiplatelet therapy with aspirin and P2Y12 receptor inhibitor vs. ticagrelor monotherapy at 3 months after PCI in patients with ST-elevation myocardial infarction.
Detailed Description
The purpose of this study is to compare the use of ticagrelor alone versus P2Y12 receptor inhibitor and aspirin together after PCI among ST-elevation myocardial infarction patients who complete 3-month course of dual antiplatelet therapy. The object of this study is to determine the effectiveness and safety of ticagrelor alone, compared to P2Y12 receptor inhibitor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among patients diagnosed with ST-elevation myocardial infarction undergoing PCI with second-generation drug-eluting stent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1002 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor monotherapy
Arm Type
Experimental
Arm Description
Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)
Arm Title
Aspirin with P2Y12 receptor inhibitor
Arm Type
Active Comparator
Arm Description
Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)
Intervention Type
Drug
Intervention Name(s)
ticagrelor monotherapy
Other Intervention Name(s)
Study group
Intervention Description
• Drug: ticagrelor monothearpy after first 3 months dual therapy
Intervention Type
Drug
Intervention Name(s)
Aspirin with P2Y12 receptor inhibitor
Other Intervention Name(s)
Control group
Intervention Description
• Drug: aspirin plus ticagrelor dual therapy during 12 months
Primary Outcome Measure Information:
Title
NACE: net clinical adverse event
Description
The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)
Time Frame
12 months after randomization
Title
Major adverse cardiac and cerebrovaascular event(MACCE)
Description
Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis
Time Frame
12 months after randomization
Title
Major bleeding (BARC type 3,5)
Description
The number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). type 3a: Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding, type 3b: Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents, type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision, type 5a: Probable fatal bleeding, type 5b: Definite fatal bleeding (overt or autopsy or imaging confirmation in accordance with BARC Definitions
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Individual component of MACCE and bleeding episode
Description
All-cause mortality :Individual component of MACCE Acute MI :Individual component of MACCE Cerebrovascular event :Individual component of MACCE Stent thrombosis :Definite or probable stent thrombosis defined by Academic Research Consortium (ARC) Bleeding :Bleeding Academic Research Consortium (BARC) type 3 or 5
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 19 years old Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS Provision of informed consent Exclusion Criteria: Age > 80 years Pregnant women or women with potential childbearing Life expectancy < 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyungil Park, Ph.D
Phone
82-51-240-2733
Email
cardiopark@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungil Park, Ph.D
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine,Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyungil Park, MD
Phone
82-51-240-2733
Email
sotier@dau.ac.kr
First Name & Middle Initial & Last Name & Degree
YoungRak Cho, MD
Phone
82-10-8553-0723
Email
progress2090@gmail.com

12. IPD Sharing Statement

Learn more about this trial

3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI

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