Short and Optimal Duration of Dual Antiplatelet Therapy Study (STOPDAPT)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Thienopyridine for 3 months

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.

• Study Type: Interventional
• Enrollment (Actual): 1525
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Department of Cardiovascular Medicine, Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thienopyridine; Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents	Drug: Thienopyridine for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular and bleeding events	Composite of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis (definite stent thrombosis not resulting in myocardial infarction), and major bleeding (TIMI Major/Minor) Cardiovascular death, myocardial infarction and stent thrombosis are defined according to the definition in the Academic Research Consortium (ARC). Stroke is defined as ischemic or hemorrhagic stroke with symptoms lasting > 24 hour. Major bleeding is defined according to the definition in the Thrombosis in Myocardial Infarction (TIMI).	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death/MI/stroke/definite ST	Composite of cardiovascular death, myocardial infarction, stroke, and definite stent thrombosis	1-year
Major bleeding (TIMI Major/Minor)	Major bleeding (TIMI Major/Minor)	1-year
Death/MI	Composite of all-cause death and myocardial infarction	1-year
All-cause death	All-cause death	1-year
Cardiovascular death/MI	Composite of cardiovascular death and myocardial infarction	1-year
Cardiovascular death	Cardiovascular death	1-year
MI	Myocardial infarction	1-year
Stroke	Both ischemic and hemorrhagic stroke excluding transient ischemic attack	1-year
Stent Thrombosis	Stent thrombosis according to Academic Research Consortium classification	1-year
Target Lesion Failure	Composite of cardiovascular death, myocardial infarction due to target vessel, and target lesion revascularization	1-year
Target Vessel Failure	Composite of cardiovascular death, myocardial infarction, and target vessel revascularization	1-year
Major Adverse Cardiac Events	Composite of cardiovascular death, myocardial infarction, and clinically-driven target lesion revascularization	1-year
Target Lesion Revascularization	Target lesion revascularization	1-year
Clinically-driven Target Lesion Revascularization	Clinically-driven Target Lesion Revascularization	1-year
Non Target Lesion Revascularization	Revascularization for non-target vessel or target vessel but target lesion	1-year
CABG	Coronary artery bypass graft	1-year
Target Vessel Revascularization	Target vessel revascularization	1-year
Any bleeding	Any bleeding complications	1-year

Collaborators and Investigators

• Sponsor: Takeshi Morimoto
• Investigators: Principal Investigator: Takeshi Kimura, MD, PhD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Anti-platelet therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: C-645