Short and Optimal Duration of Dual Antiplatelet Therapy Study

NCT ID: NCT01659034

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.

Detailed Description

"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.

With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.

Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.

Conditions

Coronary Artery Disease

Keywords

Anti-platelet therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thienopyridine

Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents

Group Type: EXPERIMENTAL

Thienopyridine for 3 months

Intervention Type: DRUG

Interventions

Thienopyridine for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who received PCI using everolimus-eluting cobalt-chromium stents

Exclusion Criteria

• Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeshi Morimoto

OTHER

Sponsor Role: lead

Responsible Party

Takeshi Morimoto

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Takeshi Kimura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Cardiovascular Medicine, Kyoto University Hospital

Kyoto, Kyoto, Japan

Countries

Japan

Other Identifiers

C-645

Identifier Type: -

Identifier Source: org_study_id