ShorT and OPtimal duration of Dual AntiPlatelet Therapy-3 study

JRCT ID: jRCTs052200114

Registered date:19/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ischemic heart disease, stable angina, myocardial infarction
• Date of first enrollment: 29/01/2021
• Target sample size: 6000
• Study type: Interventional

Intervention(s)

Intervention group:
After allocation immediately prior to PCI with Xience, antiplatelet therapy with prasugrel alone without aspirin for 1 month, followed by treatment with clopidogrel alone for up to 1-year post-PCI (aspirin-free group)

Control group:
One month of dual antiplatelet therapy with aspirin and prasugrel (DAPT) after allocation immediately prior to PCI with Xience, followed by treatment with aspirin alone for up to 1-year post-PCI (1-month DAPT group)

Outcome(s)

Primary Outcome

The primary analysis of the study will be on the primary and secondary endpoints 1 month after stent implantation. Secondary analyses will be performed on the primary and major secondary endpoints and death at 2 months after stenting. Exploratory Analysis will be performed on the primary and secondary endpoints at 1-year post-stenting.

The following two endpoints will be the primary and secondary endpoints of this study, respectively They will be evaluated at 1, 2, and 12 months after enrollment.

1. Major bleeding endpoint (BARC 3 or 5 bleeding) at 1-month (Superiority)
2. Cardiovascular composite endpoint: cardiovascular death, myocardial infarction (MI),
ischemic stroke or definite stent thrombosis (ST) at 1-month (Non-inferiority)

Secondary Outcome

The following will be the major secondary endpoints of this study. Patients will be evaluated at 1 month, 2 months, and 12 months after enrollment.
# Cardiovascular death/ MI/ ischemic stroke/ definite ST/ Major bleeding (BARC 3 or 5)

The following will be the secondary endpoints of this study.
Patients will be evaluated at 1 month and 12 months after enrollment.
Death will be evaluated at 1, 2 and 12 months.
# Death
# Cardiovascular death
# MI
# Stroke
# Ischemic stroke
# Hemorrhagic stroke
# ST (ARC definition)
# TLF
# TVF
# Any TLR
# Clinically-driven TLR
# Non-TLR
# CABG
# Any TVR
# Any coronary revascularization
# Bleeding complications
BARC 2
BARC 3
BARC 4
BARC 5
BARC 2/3/5
TIMI major
TIMI minor
TIMI major/minor
GUSTO severe
GUSTO moderate
GUSTO moderate/severe
# Intracranial bleeding
# Gastrointestinal bleeding
# Gastrointestinal complaints

The number of deaths will be analyzed from the perspective of the safety assessment of this study, including cases in which consent was withdrawn.

Key inclusion & exclusion criteria

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

Include criteria

# Patients who are planned to have PCI with exclusive use of EES (XienceTM series).
# Patients with ARC-HBR or ACS
# Patients who could take DAPT with aspirin and P2Y12 inhibitors for 1-month

• Exclude criteria: # Patients who withdraw consent (Included in the safety analysis set)

Related Information

• Primary Sponsor: Ono Koh
• Secondary Sponsor: Kimura Takeshi
• Source(s) of Monetary Support: Abbott Medical Japan, Co., Ltd.,Research Institute for Production Development
• Secondary ID(s): NCT04609111