ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS

Coronary Artery Disease Clinical Trial

— STOPDAPT-2 ACS  

Official title:

Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03462498
• Other study ID #: C1348
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 2, 2018
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2023
• 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) under the setting of acute coronary syndrome (ACS).

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. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with 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 already planned and started 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 (STOPDAPT-2; NCT02619760), where 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. In STOPDAPT-2, 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. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3008
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2021
• 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 under the setting of acute coronary syndrome
• Patients who are capable of oral dual antiplatelet therapy consisting of aspirin 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 implanted at the time of enrollment
• Patients confirmed to have no tolerability to clopidogrel before enrollment
• Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors
• Syndrome

Intervention

Drug:
• 1-months DAPT
1-month DAPT followed by 59-month monotherapy
• 12-month DAPT
12-month DAPT followed by 48-month monotherapy

Locations

Country	Name	City	State
Japan	Kyoto University Graduate School of Medicine	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 defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group		12 months
Primary	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		60 months
Secondary	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke		12 months
Secondary	Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke		60 months
Secondary	Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group		12 months
Secondary	Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group		60 months
Secondary	Upper gastrointestinal endoscopic examination or treatment		60 months
Secondary	Composite event of all-cause death/myocardial infarction		12 months
Secondary	Composite event of all-cause death/myocardial infarction		60 months
Secondary	All-cause death		12 months
Secondary	All-cause death		60 months
Secondary	Composite event of cardiovascular death/myocardial infarction		12 months
Secondary	Composite event of cardiovascular death/myocardial infarction		60 months
Secondary	Cardiovascular death		12 months
Secondary	Cardiovascular death		60 months
Secondary	Myocardial infarction		12 months
Secondary	Myocardial infarction		60 months
Secondary	Stroke		12 months
Secondary	Stroke		60 months
Secondary	Definite stent thrombosis	Academic Research Consortium definition	12 months
Secondary	Definite stent thrombosis	Academic Research Consortium definition	60 months
Secondary	Target lesion failure		12 months
Secondary	Target lesion failure		60 months
Secondary	Target vessel failure		12 months
Secondary	Target vessel failure		60 months
Secondary	Major adverse cardiac event	Composite of cardiac death, myocardial infarction, and clinically-driven TLR	12 months
Secondary	Major adverse cardiac event	Composite of cardiac death, myocardial infarction, and clinically-driven TLR	60 months
Secondary	Target lesion revascularization		12 months
Secondary	Target lesion revascularization		60 months
Secondary	Clinically-driven target lesion revascularization		12 months
Secondary	Clinically-driven target lesion revascularization		60 months
Secondary	Non target lesion revascularization		12 months
Secondary	Non target lesion revascularization		60 months
Secondary	Coronary artery bypass graft		12 months
Secondary	Coronary artery bypass graft		60 months
Secondary	Target vessel revascularization		12 months
Secondary	Target vessel revascularization		60 months
Secondary	Any coronary revascularization		12 months
Secondary	Any coronary revascularization		60 months
Secondary	Bleeding complications		12 months
Secondary	Bleeding complications		60 months
Secondary	Gastrointestinal bleeding		12 months
Secondary	Gastrointestinal bleeding		60 months
Secondary	Gastrointestinal complaints requiring upper gastrointestinal endoscopy		12 months
Secondary	Gastrointestinal complaints requiring upper gastrointestinal endoscopy		60 months
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 months