ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS
- Conditions
- Acute Myocardial InfarctionPlatelet Aggregation InhibitorsAcute Coronary SyndromeCoronary Artery DiseasePercutaneous Coronary Intervention
- Interventions
- Registration Number
- NCT03462498
- Lead Sponsor
- Kyoto University, Graduate School of Medicine
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3008
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12-month DAPT 12-month DAPT 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months 1-month DAPT 1-months DAPT 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Non target lesion revascularization 60 months Composite event of all-cause death/myocardial infarction 60 months Upper gastrointestinal endoscopic examination or treatment 60 months Bleeding complications 60 months Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke 60 months Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group 60 months Target lesion failure 60 months Target vessel failure 60 months Major adverse cardiac event 60 months Composite of cardiac death, myocardial infarction, and clinically-driven TLR
Target lesion revascularization 60 months All-cause death 60 months Myocardial infarction 60 months Clinically-driven target lesion revascularization 60 months Gastrointestinal complaints requiring upper gastrointestinal endoscopy 60 months Composite event of cardiovascular death/myocardial infarction 60 months Cardiovascular death 60 months Stroke 60 months Definite stent thrombosis 60 months Academic Research Consortium definition
Target vessel revascularization 60 months Newly diagnosed cancer 60 months 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.
Coronary artery bypass graft 60 months Gastrointestinal bleeding 60 months Any coronary revascularization 60 months
Trial Locations
- Locations (1)
Kyoto University Graduate School of Medicine
šÆšµKyoto, Japan