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

ST Elevation Myocardial Infarction Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570345
• Other study ID #: DAUHIRB-20-162
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: August 2022

Study information

• Verified date: December 2020
• Source: Dong-A University
• Contact: Kyungil Park, Ph.D
• Phone: 82-51-240-2733
• Email: cardiopark[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1002
• Est. completion date: August 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• ticagrelor monotherapy
• Drug: ticagrelor monothearpy after first 3 months dual therapy
• Aspirin with P2Y12 receptor inhibitor
• Drug: aspirin plus ticagrelor dual therapy during 12 months

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine,Dong-A University College of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NACE: net clinical adverse event	The sum of major adverse cardiac and cerebrovaascular event(MACCE) and bleeding event(BARC score)	12 months after randomization
Primary	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	12 months after randomization
Primary	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	12 months after randomization
Secondary	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	12 months after randomization