ST Elevation Myocardial InfarctionPhase 4BULK-STEMINCT04570345
3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI
A Phase 4 study testing ticagrelor monotherapy and Aspirin with P2Y12 receptor inhibitor in people with ST Elevation Myocardial Infarction, run by Dong-A University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- ticagrelor monotherapy and Aspirin with P2Y12 receptor inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 19 years old
- Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
- Provision of informed consent
Who cannot join
- Age > 80 years
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine,Dong-A University College of Medicine
Busan
Kyungil Park, MD, 82-51-240-2733, sotier@dau.ac.kr
YoungRak Cho, MD, 82-10-8553-0723, progress2090@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- ticagrelor monotherapy, Aspirin with P2Y12 receptor inhibitor
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelor monotherapyDrug
Also called Study group
- Drug: ticagrelor monothearpy after first 3 months dual therapy
Aspirin with P2Y12 receptor inhibitorDrug
Also called Control group
- Drug: aspirin plus ticagrelor dual therapy during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor monotherapy | Experimental | Ticagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor) Receives: Drug: ticagrelor monotherapy |
| Aspirin with P2Y12 receptor inhibitor | Active comparator | Aspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor) Receives: Drug: ticagrelor monotherapy; Drug: Aspirin with P2Y12 receptor inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE: net clinical adverse event
The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)
Measured: 12 months after randomization
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
Measured: 12 months after randomization
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
Measured: 12 months after randomization
Secondary outcomes (1)
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
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,002 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyungil Park, Dong-A University
- Investigators
- Kyungil Park, Ph.D, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570345
- Sponsor's protocol ID
- DAUHIRB-20-162
- Acronym
- BULK-STEMI
- Status last verified
- Dec 2020
- First submitted
- 25 Sep 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)
- ClinicalTrials.gov ID
- NCT04570345
- Acronym / sponsor ID
- BULK-STEMI / DAUHIRB-20-162
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,002 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor monotherapy | Experimental | Drug: ticagrelor monotherapyTicagrelor monotherapy after 3-month DAPT(aspirin with ticagrelor) |
| Aspirin with P2Y12 receptor inhibitor | Active comparator | Drug: ticagrelor monotherapy, Drug: Aspirin with P2Y12 receptor inhibitorAspirin with P2Y12 receptor inhibitor after 3-month DAPT(aspirin with ticagrelor) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 19 years old
- Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
- Provision of informed consent
Key exclusion criteria (3 listed)
- Age > 80 years
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ticagrelor monotherapyAlso: Study group• Drug: ticagrelor monothearpy after first 3 months dual therapy | Drug | Aspirin with P2Y12 receptor inhibitor, Ticagrelor monotherapy |
| Aspirin with P2Y12 receptor inhibitorAlso: Control group• Drug: aspirin plus ticagrelor dual therapy during 12 months | Drug | Aspirin with P2Y12 receptor inhibitor |
Primary outcome
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)
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
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
1 secondary outcome
Individual component of MACCE and bleeding episode
Time frame: 12 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyungil Park, Ph.D principal investigator
Dong-A University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor monotherapy and Aspirin with P2Y12 receptor inhibitor in people with ST Elevation Myocardial Infarction, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyungil Park, Ph.D (82-51-240-2733, cardiopark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE: net clinical adverse event (time frame: 12 months after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.