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

Dong-A University

Status and phase: Unknown; Phase 4

Conditions: ST Elevation Myocardial Infarction

Treatments: Drug: ticagrelor monotherapy; Drug: Aspirin with P2Y12 receptor inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04570345

DAUHIRB-20-162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,002 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,002 participants in 2 patient groups

Ticagrelor monotherapy

Experimental group

Description:

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

Treatment:

Drug: ticagrelor monotherapy

Aspirin with P2Y12 receptor inhibitor

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin with P2Y12 receptor inhibitor

Drug: ticagrelor monotherapy