Clinical trial NCT03462498: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Coronary Artery Disease
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Keywords: Acute Coronary Syndrome
Acute Myocardial Infarction
Coronary Artery Disease
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 3008
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 60 months
Secondary outcomes:
measure: Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
timeFrame: 12 months
measure: Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
timeFrame: 60 months
measure: Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
timeFrame: 12 months
measure: Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
timeFrame: 60 months
measure: Upper gastrointestinal endoscopic examination or treatment
timeFrame: 60 months
measure: Composite event of all-cause death/myocardial infarction
timeFrame: 12 months
measure: Composite event of all-cause death/myocardial infarction
timeFrame: 60 months
measure: All-cause death
timeFrame: 12 months
measure: All-cause death
timeFrame: 60 months
measure: Composite event of cardiovascular death/myocardial infarction
timeFrame: 12 months
measure: Composite event of cardiovascular death/myocardial infarction
timeFrame: 60 months
measure: Cardiovascular death
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 60 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 60 months
measure: Stroke
timeFrame: 12 months
measure: Stroke
timeFrame: 60 months
measure: Definite stent thrombosis
timeFrame: 12 months
measure: Definite stent thrombosis
timeFrame: 60 months
measure: Target lesion failure
timeFrame: 12 months
measure: Target lesion failure
timeFrame: 60 months
measure: Target vessel failure
timeFrame: 12 months
measure: Target vessel failure
timeFrame: 60 months
measure: Major adverse cardiac event
timeFrame: 12 months
measure: Major adverse cardiac event
timeFrame: 60 months
measure: Target lesion revascularization
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 60 months
measure: Clinically-driven target lesion revascularization
timeFrame: 12 months
measure: Clinically-driven target lesion revascularization
timeFrame: 60 months
measure: Non target lesion revascularization
timeFrame: 12 months
measure: Non target lesion revascularization
timeFrame: 60 months
measure: Coronary artery bypass graft
timeFrame: 12 months
measure: Coronary artery bypass graft
timeFrame: 60 months
measure: Target vessel revascularization
timeFrame: 12 months
measure: Target vessel revascularization
timeFrame: 60 months
measure: Any coronary revascularization
timeFrame: 12 months
measure: Any coronary revascularization
timeFrame: 60 months
measure: Bleeding complications
timeFrame: 12 months
measure: Bleeding complications
timeFrame: 60 months
measure: Gastrointestinal bleeding
timeFrame: 12 months
measure: Gastrointestinal bleeding
timeFrame: 60 months
measure: Gastrointestinal complaints requiring upper gastrointestinal endoscopy
timeFrame: 12 months
measure: Gastrointestinal complaints requiring upper gastrointestinal endoscopy
timeFrame: 60 months
measure: Newly diagnosed cancer
timeFrame: 60 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1.
citation: Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244.