Short and Optimal Duration of Dual Antiplatelet Therapy Study

Coronary Artery Disease Clinical Trial

— STOPDAPT  

Official title:

Short and Optimal Duration of Dual Antiplatelet Therapy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659034
• Other study ID #: C-645
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2012
• Last updated: December 9, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1525
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Thienopyridine for 3 months

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

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