ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study (STOPDAPT-2)

Completed

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

• Registration Number: jRCTs052180194

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-28
• Study First Submitted: 2019-03-26
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3000

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: parallel assignment

Primary Outcome Measures

Name	Time	Method
primary endpoint of primary analysis	12 months	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)
primary endpoint of secondary analysis	60 months	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)

Secondary Outcome Measures

Name	Time	Method
Large MI		CKMB>=10 times of upper limit of normal [ULN]
Stroke		ischemic/hemorrhagic
Small MI		CKMB<10 times of ULN
Stent thrombosis		definite, probable, definite/probable in ARC definition
Bleeding		TIMI criteria, BARC criteria, and GUSTO criteria
MACE		composite of death from cardiac cause. MI and clinically-driven TLR