ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

Coronary Artery Disease Clinical Trial

— STOPDAPT-2  

Official title:

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619760
• Other study ID #: C1114
• Secondary ID: UMIN000019948
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3045
• Est. completion date: December 31, 2023
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Japan	Division of Cardiology, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group	12-month
Secondary	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke		12-month
Secondary	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke		60-month
Secondary	Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group		12-month
Secondary	Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group		60-month
Secondary	Upper gastrointestinal endoscopic examination or treatment		60-month
Secondary	Composite event of all-cause death/myocardial infarction		12-month
Secondary	Composite event of all-cause death/myocardial infarction		60-month
Secondary	All-cause death		12-month
Secondary	All-cause death		60-month
Secondary	Composite event of cardiovascular death/myocardial infarction		12-month
Secondary	Composite event of cardiovascular death/myocardial infarction		60-month
Secondary	Cardiovascular death		12-month
Secondary	Cardiovascular death		60-month
Secondary	Myocardial infarction		12-month
Secondary	Myocardial infarction		60-month
Secondary	Stroke	a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage	12-month
Secondary	Stroke	a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage	60-month
Secondary	MACE (Major Adverse Cardiac Events)	Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization	12-month
Secondary	MACE (Major Adverse Cardiac Events)	Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization	60-month
Secondary	Definite stent thrombosis		12-month
Secondary	Definite stent thrombosis		60-month
Secondary	Target lesion failure	Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR	12-month
Secondary	Target lesion failure	Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR	60-month
Secondary	Target vessel failure		12-month
Secondary	Target vessel failure		60-month
Secondary	Target lesion revasucularization	PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications	12-month
Secondary	Target lesion revasucularization	PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications	60-month
Secondary	Clinically-driven target lesion revascularization	the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for = 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.	12-month
Secondary	Clinically-driven target lesion revascularization	the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for = 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.	60-month
Secondary	Non target lesion revascularization		12-month
Secondary	Non target lesion revascularization		60-month
Secondary	Coronary artery bypass graft		12-month
Secondary	Coronary artery bypass graft		60-month
Secondary	Target vessel revascularization		12-month
Secondary	Target vessel revascularization		60-month
Secondary	Any coronary reascluarization		12-month
Secondary	Any coronary reascluarization		60-month
Secondary	Bleeding complications	Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)	12-month
Secondary	Bleeding complications	Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)	60-month
Secondary	Gastrointestinal bleeding	Bleeding events requiring upper gastrointestinal endoscopic study or treatment.	12-month
Secondary	Gastrointestinal bleeding	Bleeding events requiring upper gastrointestinal endoscopic study or treatment.	60-month
Secondary	Gastrointestinal complaints	Symptoms requiring upper gastrointestinal endoscopic study or treatment	12-month
Secondary	Gastrointestinal complaints	Symptoms requiring upper gastrointestinal endoscopic study or treatment	60-month
Secondary	Newly diagnosed cancer	The endpoint is a newly diagnosed malignancy during the follow-up period that has not been previously diagnosed before enrollment. This does not include recurrent tumor after remission, includes early-stage cancer eligible for endoscopic treatment, and includes the tumors which are not diagnosed by tissue biopsy but are judged to be clinically malignant on imaging.	60-month