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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01267734
First received: December 27, 2010
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

Objectives

  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. 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)

Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients

  1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure (TLF)
  2. 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.

Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea

Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the procedure. Angiographical follow-up will be recommended to all participants at 13 months after the procedure. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary endpoint

  1. 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
  2. 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

Condition Intervention Phase
Coronary Heart Disease
Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element)
Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute)
Drug: Triple anti-platelet therapy (TAT)
Drug: Double-dose clopidogrel anti-platelet therapy (DDAT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of New Platform Everolimus-eluting Coronary Stent System (Promus Element) With Zotarolimus-eluting Coronary Stent System (Endeavor Resolute) and Triple Anti-platelet Therapy With Double-dose Clopidogrel Anti-platelet Therapy in Patients With Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Target lesion failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR)

  • Net clinical outcome [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria


Estimated Enrollment: 3750
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EECSS + DDAT
Promus Element stent + double-dose clopidogrel anti-platelet therapy
Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element)
Everolimus-eluting stent
Other Name: Promus Element
Drug: Double-dose clopidogrel anti-platelet therapy (DDAT)
100mg Aspirin QD + 150mg Clopidogrel QD for 1 month
Active Comparator: ZECSS + DDAT
Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy
Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute)
Zotarolimus-eluting stent
Other Name: Endeavor Resolute
Drug: Double-dose clopidogrel anti-platelet therapy (DDAT)
100mg Aspirin QD + 150mg Clopidogrel QD for 1 month
Experimental: EECSS + TAT
Promus Element stent + triple anti-platelet therapy
Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element)
Everolimus-eluting stent
Other Name: Promus Element
Drug: Triple anti-platelet therapy (TAT)
100mg Aspirin QD + 75mg Clopidogrel QD + 100mg Cilostazol BID for 1 month
Active Comparator: ZECSS + TAT
Endeavor Resolute stent + triple anti-platele therapy
Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute)
Zotarolimus-eluting stent
Other Name: Endeavor Resolute
Drug: Triple anti-platelet therapy (TAT)
100mg Aspirin QD + 75mg Clopidogrel QD + 100mg Cilostazol BID for 1 month

Detailed Description:

Secondary endpoint

  1. Clinical and laboratory endpoint at 1 month All death and cardiac death Myocardial infarction (q wave and non-q wave) Stent thrombosis (definite and possible) CVA (hemorrhagic and non-hemorrhagic) Bleeding (major and minor) VerifyNow ASA and VerifyNow P2Y12
  2. Clinical endpoint at 12 months All death and cardiac death Target vessel-related MI and all MI (q wave and non-q wave) Target vessel/lesion revascularization (ischemia-driven and all) Stent thrombosis (definite/possible/probable) Net clinical outcome including bleeding (major and minor) Acute success of procedure (device, lesion and procedure)
  3. Angiographic (including IVUS or OCT) endpoint at 13 months In-stent & In-segment late loss In-stent & In-segment % diameter stenosis Angiographic pattern of restenosis Neointimal volume, % neointimal volume and % volume obstruction on IVUS or OCT Degree of stent strut endothelialization on OCT
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria

  • 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.

Angiographic Inclusion Criteria

  • 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.

Exclusion criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267734

Contacts
Contact: Kyung Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr
Contact: Hyo-Soo Kim, MD, PhD 82-2-2072-2226 hyosoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Woo Park, MD, PhD    82-2-2072-0244    kwparkmd@snu.ac.kr   
Contact: Hyo-Soo Kim, MD, PhD    82-2-2072-2226    hyosoo@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Boston Scientific Corporation
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01267734     History of Changes
Other Study ID Numbers: HOST-ASSURE
Study First Received: December 27, 2010
Last Updated: December 15, 2013
Health Authority: Republic of Korea : Institutional Review Board

Keywords provided by Seoul National University Hospital:
Everolimus
Zotarolimus
Cilostazol
Clopidogrel

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Clopidogrel
Ticlopidine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014