Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen

NCT01267734 | Unknown Phase 4 DMC

• 1 other identifier: HOST-ASSURE
• Study Type: interventional
• Target: 3,750
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives

1. 1.To compare the safety and long-term effectiveness of coronary stenting with the new platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in patients with coronary heart disease (CHD)
2. 2.To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT, Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES)
3. 3.Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure (TLF)
4. 4.Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT). Randomization will also be stratified per presence of DM.
5. 5.Target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) up to 12 months for the stent arm
6. 6.Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria at 1 month for the anti-platelet arm

Conditions

Coronary Heart Disease

Keywords

Everolimus; Zotarolimus; Cilostazol; Clopidogrel

Outcome Measures

Primary Outcomes (2)

• Target lesion failure (TLF)

  Composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR)

  12 months

• Net clinical outcome

  Composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria

  1 month

Study Arms (4)

EECSS + DDAT

EXPERIMENTAL

Promus Element stent + double-dose clopidogrel anti-platelet therapy

Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element); Drug: Double-dose clopidogrel anti-platelet therapy (DDAT)

ZECSS + DDAT

ACTIVE COMPARATOR

Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy

Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute); Drug: Double-dose clopidogrel anti-platelet therapy (DDAT)

EECSS + TAT

EXPERIMENTAL

Promus Element stent + triple anti-platelet therapy

Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element); Drug: Triple anti-platelet therapy (TAT)

ZECSS + TAT

ACTIVE COMPARATOR

Endeavor Resolute stent + triple anti-platele therapy

Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute); Drug: Triple anti-platelet therapy (TAT)

Interventions

Everolimus-eluting coronary stenting system (EECSS, Promus Element) DEVICE

Everolimus-eluting stent

Also known as: Promus Element

EECSS + DDAT; EECSS + TAT

Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute) DEVICE

Zotarolimus-eluting stent

Also known as: Endeavor Resolute

ZECSS + DDAT; ZECSS + TAT

Triple anti-platelet therapy (TAT) DRUG

100mg Aspirin QD + 75mg Clopidogrel QD + 100mg Cilostazol BID for 1 month

EECSS + TAT; ZECSS + TAT

Double-dose clopidogrel anti-platelet therapy (DDAT) DRUG

100mg Aspirin QD + 150mg Clopidogrel QD for 1 month

EECSS + DDAT; ZECSS + DDAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age.
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Promus Element or Endeavor Resolute stents, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have significant lesion (\>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia). In subjects with diameter stenosis \> 70%, evidence of myocardial ischemia does not have to be documented.
• Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.00 mm.
• Target lesion(s) must be amenable for percutaneous coronary intervention.

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol, Everolimus, Zotarolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
• Systemic (intravenous) Everolimus or Zotarolimus use within 12 months.
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), abnormal hemogram (Hb\<10g/dL or PLT count \<100,000/μL) or will refuse blood transfusions
• Patients with severe LV systolic dysfunction (LVEF\<25%) or cardiogenic shock
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Symptomatic heart failure

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (3)

• Park KW, Kang SH, Kang HJ, Koo BK, Park BE, Cha KS, Rhew JY, Jeon HK, Shin ES, Oh JH, Jeong MH, Kim S, Hwang KK, Yoon JH, Lee SY, Park TH, Moon KW, Kwon HM, Hur SH, Ryu JK, Lee BR, Park YW, Chae IH, Kim HS; HOST-ASSURE Investigators. A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2805-16. doi: 10.1016/j.jacc.2014.04.013. Epub 2014 May 7.

  PMID: 24814486 DERIVED

• Park KW, Kang SH, Park JJ, Yang HM, Kang HJ, Koo BK, Park BE, Cha KS, Rhew JY, Jeon HK, Shin ES, Oh JH, Jeong MH, Kim S, Hwang KK, Yoon JH, Lee SY, Park TH, Moon KW, Kwon HM, Chae IH, Kim HS. Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen). JACC Cardiovasc Interv. 2013 Sep;6(9):932-42. doi: 10.1016/j.jcin.2013.04.022.

  PMID: 24050860 DERIVED

• Park KW, Park BE, Kang SH, Park JJ, Lee SP, Cha KS, Rhew JY, Jeon HK, Shin ES, Oh JH, Jeong MH, Kim S, Hwang KK, Yoon JH, Lee SY, Park TH, Moon KW, Kwon HM, Chae IH, Kim HS; HOST investigators. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial. Trials. 2012 Mar 31;13:29. doi: 10.1186/1745-6215-13-29.

  PMID: 22463698 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Hyo-Soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Kyung Woo Park, MD, PhD

CONTACT

82-2-2072-0244; kwparkmd@snu.ac.kr

Hyo-Soo Kim, MD, PhD

CONTACT

82-2-2072-2226; hyosoo@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2015
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

KR (1)