The study to evaluate ShorT and OPtimal duration of Dual AntiPlatelet Therapy for the patients with ACS

Phase 4

• Conditions: Coronary Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina

• Registration Number: JPRN-UMIN000029981
• Lead Sponsor: Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine

Brief Summary

In the pooled 4136 patients, 2058 were assigned into the 1-month DAPT group and 2078 were assigned into the 12-month DAPT group. The 1-year incidence rate of the primary end point comprising cardiovascular and bleeding events was 3.2% in those in the 1-month DAPT group and 2.8% in the 12-month DAPT group, which did not meet the noninferiority of the 1-month DAPT group.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Results First Posted: 2022-03-02
• Last Update Posted: 17 October 2023
• Study Completion: 2025-03-04

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 3008

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients requiring oral anticoagulants 2. Patients with medical history of intracranial hemorrhage 3. Patients who have experienced serious complications (MI, stroke, and major bleeding) during hospital stay post-PCI 4. Patients with DES other than Xience implanted in PCI performed at the time of enrollment 5. Patients confirmed to have no tolerability to clopidogrel before enrollment 6. Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor inhibitors (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment 7. Patients with coronary bioabsorbable vascular scaffold (BVS) implanted prior to or at the time of enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of cardiovascular death, myocardial infarction (MI), stroke (ischemic and hemorrhagic), stent thrombosis (Definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 12 months after index PCI.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor) at 12 months after index PCI. Cardiovascular death, MI, Stroke, ARC definite ST, Major bleeding (TIMI Major/ Minor), Upper gastrointestinal endoscopy / upper gastrointestinal endoscopic treatment at 60 months after index PCI.