Clinical trial NCT02619760: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Official title: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 3045
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
timeFrame: 12-month
Secondary outcomes:
measure: Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
timeFrame: 12-month
measure: Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
timeFrame: 60-month
measure: Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
timeFrame: 12-month
measure: Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
timeFrame: 60-month
measure: Upper gastrointestinal endoscopic examination or treatment
timeFrame: 60-month
measure: Composite event of all-cause death/myocardial infarction
timeFrame: 12-month
measure: Composite event of all-cause death/myocardial infarction
timeFrame: 60-month
measure: All-cause death
timeFrame: 12-month
measure: All-cause death
timeFrame: 60-month
measure: Composite event of cardiovascular death/myocardial infarction
timeFrame: 12-month
measure: Composite event of cardiovascular death/myocardial infarction
timeFrame: 60-month
measure: Cardiovascular death
timeFrame: 12-month
measure: Cardiovascular death
timeFrame: 60-month
measure: Myocardial infarction
timeFrame: 12-month
measure: Myocardial infarction
timeFrame: 60-month
measure: Stroke
timeFrame: 12-month
measure: Stroke
timeFrame: 60-month
measure: MACE (Major Adverse Cardiac Events)
timeFrame: 12-month
measure: MACE (Major Adverse Cardiac Events)
timeFrame: 60-month
measure: Definite stent thrombosis
timeFrame: 12-month
measure: Definite stent thrombosis
timeFrame: 60-month
measure: Target lesion failure
timeFrame: 12-month
measure: Target lesion failure
timeFrame: 60-month
measure: Target vessel failure
timeFrame: 12-month
measure: Target vessel failure
timeFrame: 60-month
measure: Target lesion revasucularization
timeFrame: 12-month
measure: Target lesion revasucularization
timeFrame: 60-month
measure: Clinically-driven target lesion revascularization
timeFrame: 12-month
measure: Clinically-driven target lesion revascularization
timeFrame: 60-month
measure: Non target lesion revascularization
timeFrame: 12-month
measure: Non target lesion revascularization
timeFrame: 60-month
measure: Coronary artery bypass graft
timeFrame: 12-month
measure: Coronary artery bypass graft
timeFrame: 60-month
measure: Target vessel revascularization
timeFrame: 12-month
measure: Target vessel revascularization
timeFrame: 60-month
measure: Any coronary reascluarization
timeFrame: 12-month
measure: Any coronary reascluarization
timeFrame: 60-month
measure: Bleeding complications
timeFrame: 12-month
measure: Bleeding complications
timeFrame: 60-month
measure: Gastrointestinal bleeding
timeFrame: 12-month
measure: Gastrointestinal bleeding
timeFrame: 60-month
measure: Gastrointestinal complaints
timeFrame: 12-month
measure: Gastrointestinal complaints
timeFrame: 60-month
measure: Newly diagnosed cancer
timeFrame: 60-month
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
name: Takeshi Kimura, MD, PhD
role: STUDY_CHAIR
References:
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