ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study for patients with ACS

JRCT ID: jRCTs052180193

Registered date:26/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ischemic heart disease, stable angina, myocardial infarction
• Date of first enrollment: 30/03/2018
• Target sample size: 3000
• Countries of recruitment: Only in Japan,Japan
• Study type: Interventional
• Intervention(s): Intervention: After PCI with Xience for patients with ACS, dual antiplatelet therapy (DAPT) will be performed for one month. Following that, clopidogrel monotherapy will be continued up to 5 years after index PCI (1-month DAPT group) Control: After PCI with Xience for patients with ACS, dual antiplatelet therapy (DAPT) will be performed for twelve months. Following that, aspirin monotherapy will be continued up to 5 years after index PCI (12-month DAPT group)

Outcome(s)

• Primary Outcome: 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. 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

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have undergone PCI with the everolimus-eluting cobalt-chromium stent (CoCr-EES, XienceTM) in the setting of ACS (STEMI, NSTEMI, or UA) 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

Exclude 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

Related Information

• Primary Sponsor: Ono Koh
• Secondary Sponsor: Kimura Takeshi
• Source(s) of Monetary Support: Abbott Medical Japan LLC
• Secondary ID(s): NCT03462498,UMIN000029981