ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study

Phase 4

• Conditions: Ischemic heart disease, stable angina, myocardial infarction

• Registration Number: JPRN-jRCTs052180194
• Lead Sponsor: Ono Koh

Brief Summary

For the patients receiving coronary stenting with DES, clopidogrel monotherapy following 1-month DAPT, compared with conventional aspirin monotherapy following 12-month DAPT, significantly reduced cardiovascular events at 5 years and was non-inferior in the primary endpoint, making it a promising new alternative to conventional therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Results First Posted: 2019-06-25
• Study Completion: 2023-01-04
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3045

Inclusion Criteria

1) Patients who have undergone PCI with the everolimus-eluting cobalt-chromium stent (CoCr-EES, XienceTM) and have not experienced major complications (death, MI, stroke, or major bleeding) during hospital stay for treatment
2) Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist

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 with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment (including implantation cases in clinical trial)
6) Patients confirmed to have no tolerability to clopidogrel before enrollment
7) Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor antagonists (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of primary analysis in current study is 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. Non inferiority of 1-month DAPT group will be verified compared with 12-month DAPT group.<br><br>The primary endpoint of secondary analysis is the composite of cardiovascular death, MI, stroke (ischemic or hemorrhagic), stent thrombosis (definite stent thrombosis yet to develop into MI), and severe bleeding (TIMI Major/Minor) at 60 months. Superiority of 1-month DAPT group will be verified compared with 12-month group.

Secondary Outcome Measures

Name	Time	Method
Death<br>Death from cardiac cause<br>Death from cardiovascular cause<br>Death from non-cardiovascular cause<br>MI <br>Large MI (CKMB>=10 times of upper limit of normal [ULN])<br>Small MI (CKMB<10 times of ULN)<br>MI without CKMB elevation<br>MI without measurement of CKMB<br>Stroke (ischemic/hemorrhagic)<br>Ischemic stroke<br>Hemorrhagic stroke<br>Stent thrombosis (definite, probable, definite/probable in ARC definition)<br>Bleeding (TIMI criteria, BARC criteria, and GUSTO criteria)<br>Intracranial bleeding<br>Gastrointestinal bleeding<br>MACE (composite of death from cardiac cause. MI and clinically-driven TLR)<br>Death / MI<br>Cardiovascular death/ MI <br>Any coronary revascularization<br>Any TLR<br>Clinically-driven TLR <br>Non-TLR <br>TLF<br>TVF<br>CABG<br>Newly diagnosed cancer (60 months only)