ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

NCT ID: NCT02619760

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3045 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).

Detailed Description

The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. However, serious hemorrhagic complications associated with a prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group. Primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. At first, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-month DAPT

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy

Group Type: ACTIVE_COMPARATOR

1-month DAPT

Intervention Type: DRUG

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

12-month DAPT

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy

Group Type: ACTIVE_COMPARATOR

12-month DAPT

Intervention Type: DRUG

12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Interventions

1-month DAPT

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Intervention Type: DRUG

12-month DAPT

12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
• Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist

Exclusion Criteria

• Patients requiring oral anticoagulants
• Patients with medical history of intracranial hemorrhage
• Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
• Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment
• Patients comfirmed to have no tolerability to clopidgorel before enrollment
• Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
• Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Takeshi Morimoto

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takeshi Kimura, MD, PhD

Role: STUDY_CHAIR

Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

Division of Cardiology, Kyoto University Hospital

Kyoto, , Japan

Countries

Japan

References

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Reference Type: DERIVED

PMID: 36599584 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Other Identifiers

UMIN000019948

Identifier Type: OTHER

Identifier Source: secondary_id

C1114

Identifier Type: -

Identifier Source: org_study_id