Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03462498
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2018-03-06
Brief Title:
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS
Sponsor:
Kyoto University Graduate School of Medicine
Organization:
Kyoto University Graduate School of Medicine
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOPDAPT-2 ACS
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None