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

December 18, 2020 updated by: Kyungil Park, Dong-A University

3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

1002

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Busan, Korea, Republic of
        • Recruiting
        • Department of Internal Medicine,Dong-A University College of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor monotherapy
Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor)
• Drug: ticagrelor monothearpy after first 3 months dual therapy
Other Names:
  • Study group
Active Comparator: Aspirin with P2Y12 receptor inhibitor
Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor)
• Drug: ticagrelor monothearpy after first 3 months dual therapy
Other Names:
  • Study group
• Drug: aspirin plus ticagrelor dual therapy during 12 months
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NACE: net clinical adverse event
Time Frame: 12 months after randomization
The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)
12 months after randomization
Major adverse cardiac and cerebrovaascular event(MACCE)
Time Frame: 12 months after randomization
Major adverse cardiac and cerebrovaascular event(MACCE) includes 1)all-cause motality, 2) acute MI, 3)cerebrovascular event, 4)stent thrombosis
12 months after randomization
Major bleeding (BARC type 3,5)
Time Frame: 12 months after randomization

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

12 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual component of MACCE and bleeding episode
Time Frame: 12 months after randomization
  1. All-cause mortality :Individual component of MACCE
  2. Acute MI :Individual component of MACCE
  3. Cerebrovascular event :Individual component of MACCE
  4. Stent thrombosis :Definite or probable stent thrombosis defined by Academic Research Consortium (ARC)
  5. Bleeding :Bleeding Academic Research Consortium (BARC) type 3 or 5
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyungil Park, Ph.D, Dong-A University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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