- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570345
3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI (BULK-STEMI)
3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Kyungil Park, Ph.D
- Phone Number: 82-51-240-2733
- Email: cardiopark@gmail.com
Study Locations
-
-
-
Busan, Korea, Republic of
- Recruiting
- Department of Internal Medicine,Dong-A University College of Medicine
-
Contact:
- Kyungil Park, MD
- Phone Number: 82-51-240-2733
- Email: sotier@dau.ac.kr
-
Contact:
- YoungRak Cho, MD
- Phone Number: 82-10-8553-0723
- Email: progress2090@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
• Drug: aspirin plus ticagrelor dual therapy during 12 months
Other Names:
|
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
|
|
12 months after randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyungil Park, Ph.D, Dong-A University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- DAUHIRB-20-162
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on ST Elevation Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Inha University HospitalCompletedST Segment Elevation Myocardial Infarction | Non-ST Segment Elevation Myocardial InfarctionKorea, Republic of
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
RenJi HospitalCompletedST Segment Elevation Myocardial Infarction
-
Dong-A UniversityTerminatedST-Segment Elevation Myocardial InfarctionKorea, Republic of
-
Azienda Ospedaliera San Camillo ForlaniniUnknownST Segment Elevation Myocardial InfarctionItaly
-
Jinan Central HospitalUnknownST-Segment Elevation Myocardial InfarctionChina
Clinical Trials on ticagrelor monotherapy
-
The First Affiliated Hospital with Nanjing Medical...RecruitingIntracranial Aneurysm | Stent ComplicationChina
-
University of California, San FranciscoNot yet recruitingProstate Adenocarcinoma | Localized Prostate CarcinomaUnited States
-
Masonic Cancer Center, University of MinnesotaActive, not recruiting
-
Peking Union Medical College HospitalCompletedChronic Periaortitis | Tocilizumab MonotherapyChina
-
PharmAbcineC&R Research, Inc.RecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
-
Second Affiliated Hospital of Guangzhou Medical...Not yet recruitingNon-small Cell Lung Cancer
-
Zai Lab (Shanghai) Co., Ltd.Completed
-
Seoul National University HospitalThreshold PharmaceuticalsCompletedBiliary Tract CancerKorea, Republic of
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
Tongji HospitalFirst Affiliated Hospital Xi'an Jiaotong University; Wuhan Union Hospital,... and other collaboratorsRecruitingOvarian CancerChina