NCT04570345

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,002 (estimated)
• Sponsor: Dong-A University · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-08-31
• Completion: 2022-08-01
• First posted: 2020-09-30
• Last updated: 2020-12-22

Locations

1 site across 1 country: South Korea