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A New Strategy Regarding Discontinuation of Dual Antiplatelet

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Zotarolimus-eluting stent

Zotarolimus-eluting stent for ACS and DM

Everolimus-eluting stent for long lesion

Sirolimus-eluting stent for short lesion

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
Age 20 years of older
Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
Patients with signed informed consent
Lesion and stent length for ACS and DM subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm
Lesion and stent length for ACS and DM subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm
Lesion and stent length for long lesion subgroup : Length of single stent per single lesion > 28 mm and, Summation of total length of all inserted DES in 3 vessel ≤ 90 mm, Possible overlapping stent
Lesion and stent length for short lesion subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm
Significant coronary artery stenosis (>50% by visual estimate) considered for coronary revascularization with stent implantation
Reference vessel diameter of 2.5 to 4.0 mm by operator assessment
Lesion success (30% or less residual stenosis by visual assessment over the entire stent length, with TIMI-3 flow and no more than an NHLBI type B peri-stent dissection

Exclusion Criteria:

Contraindication to anti-platelet agents & bleeding history within prior 3 months
Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, limus related drug
Prior history of the following presentations : Cerebral vascular accident (not including transient ischemic attack, Peripheral artery occlusive diseases, Thromboembolic disease, Stent thrombosis
Severe hepatic dysfunction (3 times normal reference values)
Significant renal dysfunction (Serum creatinine > 2.0 mg/dl)
Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
Cardiogenic shock
LVEF < 40%
Pregnant women or women with potential childbearing
Life expectancy 3 year
Overlapped DESs(only long lesion subgroup is possible overlapping)
Left main disease requiring PCI
Bifurcation lesion with 2-stent technique
Target lesions with in-stent restenosis at the stented segment of DES or BMS
Lesions with chronic total occlusion
History of PCI with DES
In-stent restenosis lesion

Sites / Locations

Severance Cardiovascular Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Endeavor arm

Endeavor resolute arm

Xience arm

Cypher arm

Arm Description

Outcomes

Primary Outcome Measures

Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation

Secondary Outcome Measures

Full Information

NCT ID

NCT01145079

First Posted

June 14, 2010

Last Updated

March 4, 2013

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01145079

Brief Title

A New Strategy Regarding Discontinuation of Dual Antiplatelet

Official Title

A New Strategy Regarding Discontinuation of Dual Antiplatelet; Real Safety and Efficacy of a 3-month Dual Antiplatelet Therapy Following Zotarolimus-eluting Stents Implantation (RESET Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Drug-eluting stents (DES), markedly reducing the neointimal hyperplasia after stent implantation compared with bare-metal stents (BMS), have improved angiographic and clinical outcomes in the complex lesions and patients with high risks. However, currently, the fatal events related with stent thrombosis still occur and are the major limitation of the use of DES. Especially, late or very late thrombosis after DES implantation is an uncommon but life-threatening fatal complication presented with sudden death or myocardial infarction (MI) causing heart failure. The most powerful predictor for stent thrombosis is the discontinuation of clopidogrel. In consideration of current data regarding stent thrombosis and clinical situation of discontinuation of antiplatelet, zotarolimus-eluting stent (ZES) [Endeavor®, Medtronic Vascular, Santa Rosa, CA] might be anticipated to be safer than other DES during the long-term follow-up owing to healthy endothelialization. Endeavor® stent was consists of zotarolimus, thin-strut, cobalt-chromium alloy stent platform (DriverTM stent; Medtronic Vascular, Santa Rosa, CA), and phosphorylcholine coating. The ENDEAVOR II study demonstrated clinically and statistically significant improvement in all of study endpoints, including a 47 percent reduction in the primary endpoint of target vessel failure (TVF). In addition, the ENDEAVOR II trial showed a 0.5 percent rate of stent thrombosis at 30 days - with no late thrombosis beyond 30 days and no late stent malapposition. Because reendothelialization after ZES implantation may occur within 3 months, 3-month dual antiplatelet therapy is recommended in many clinical trials and real world practice. Shorter maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in cases of discontinuation of antiplatelet and prevent waste medications and bleeding complications related with dual antiplatelet therapy. However, there have been no non-inferior or superior data of ZES considering all these circumstances. Therefore, the investigators hypothesize that ZES with 3-month dual antiplatelet therapy may be safe and beneficial in patients with coronary artery disease during follow-up than other DES, in spite of higher late lumen loss. To test this hypothesis, the investigators will perform a multi-center, randomized, prospective trial aimed at demonstrating the efficacy of the ZES versus other DES in patients with coronary artery disease in real world practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

982 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endeavor arm

Arm Type

Experimental

Arm Title

Endeavor resolute arm

Arm Type

Active Comparator

Arm Title

Xience arm

Arm Type

Active Comparator

Arm Title

Cypher arm

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Zotarolimus-eluting stent

Intervention Description

Zotarolimus-eluting stent

Intervention Type

Device

Intervention Name(s)

Zotarolimus-eluting stent for ACS and DM

Intervention Description

Zotarolimus-eluting stent for ACS and DM

Intervention Type

Device

Intervention Name(s)

Everolimus-eluting stent for long lesion

Intervention Description

Everolimus-eluting stent for long lesion

Intervention Type

Device

Intervention Name(s)

Sirolimus-eluting stent for short lesion

Intervention Description

Sirolimus-eluting stent for short lesion

Primary Outcome Measure Information:

Title

Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation

Time Frame

12 months after stent implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction Age 20 years of older Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia Patients with signed informed consent Lesion and stent length for ACS and DM subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm Lesion and stent length for ACS and DM subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm Lesion and stent length for long lesion subgroup : Length of single stent per single lesion > 28 mm and, Summation of total length of all inserted DES in 3 vessel ≤ 90 mm, Possible overlapping stent Lesion and stent length for short lesion subgroup : Length of single lesion < 24 mm and, Summation of total length of all inserted DES in 3 vessel < 60 mm Significant coronary artery stenosis (>50% by visual estimate) considered for coronary revascularization with stent implantation Reference vessel diameter of 2.5 to 4.0 mm by operator assessment Lesion success (30% or less residual stenosis by visual assessment over the entire stent length, with TIMI-3 flow and no more than an NHLBI type B peri-stent dissection Exclusion Criteria: Contraindication to anti-platelet agents & bleeding history within prior 3 months Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, limus related drug Prior history of the following presentations : Cerebral vascular accident (not including transient ischemic attack, Peripheral artery occlusive diseases, Thromboembolic disease, Stent thrombosis Severe hepatic dysfunction (3 times normal reference values) Significant renal dysfunction (Serum creatinine > 2.0 mg/dl) Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Cardiogenic shock LVEF < 40% Pregnant women or women with potential childbearing Life expectancy 3 year Overlapped DESs(only long lesion subgroup is possible overlapping) Left main disease requiring PCI Bifurcation lesion with 2-stent technique Target lesions with in-stent restenosis at the stented segment of DES or BMS Lesions with chronic total occlusion History of PCI with DES In-stent restenosis lesion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myeong Ki Hong, MD, PhD

Organizational Affiliation

Severance Cardiovascular Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Cardiovascular Hospital, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

32588238

Citation

Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.

Results Reference

derived

PubMed Identifier

30475845

Citation

Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.

Results Reference

derived

PubMed Identifier

23523455

Citation

Kim JS, Kang TS, Mintz GS, Park BE, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Randomized comparison of clinical outcomes between intravascular ultrasound and angiography-guided drug-eluting stent implantation for long coronary artery stenoses. JACC Cardiovasc Interv. 2013 Apr;6(4):369-76. doi: 10.1016/j.jcin.2012.11.009. Epub 2013 Mar 20.

Results Reference

derived

PubMed Identifier

22999717

Citation

Kim BK, Hong MK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Park BE, Kang WC, Lee SH, Yoon JH, Hong BK, Kwon HM, Jang Y; RESET Investigators. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol. 2012 Oct 9;60(15):1340-8. doi: 10.1016/j.jacc.2012.06.043. Epub 2012 Sep 19.

Results Reference

derived

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A New Strategy Regarding Discontinuation of Dual Antiplatelet

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