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Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing (EXCELLENT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott
Boston Scientific Corporation
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00698607
First received: June 15, 2008
Last updated: June 28, 2010
Last verified: June 2010
History of Changes
  Purpose

Objectives

  1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis.
  2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.

Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm)

Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.

Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint

  • In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
  • Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy

Secondary Endpoint

  • All Death
  • Cardiac death
  • Myocardial infarction
  • Target vessel revascularization (TVR) (all and ischemia-driven)
  • Target lesion revascularization (TLR) (all and ischemia-driven)
  • Stent thrombosis
  • Acute success (device, lesion, and procedure)
  • Bleeding
  • Cerebrovascular accident
  • In-stent LL at 9 months
  • Angiographic pattern of restenosis at 9-month angiographic follow-up
  • In-stent and in-segment % diameter stenosis (%DS) at 9 months
  • In-stent % volume obstruction (%VO) at 9 months
  • Incomplete stent apposition post index procedure
  • Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

Condition Intervention Phase
Coronary Artery Disease
 Device: Everolimus-eluting stent (Xience or Promus)
Device: Sirolimus-eluting stent (Cypher)
Drug: 6-month clopidogrel therapy
Drug: 12-month clopidogrel therapy
 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 of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) (all and ischemia-driven) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) (all and ischemia-driven) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Acute success (device, lesion, and procedure) [ Time Frame: Index procedure ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cerebrovascular accident [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • In-stent LL at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Angiographic pattern of restenosis at 9-month angiographic follow-up [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment % diameter stenosis (%DS) at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • In-stent % volume obstruction (%VO) at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incomplete stent apposition post index procedure [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
  • Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1466
Study Start Date: June 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E6
Everolimus-eluting stent 6-month clopidogrel therapy
 Device: Everolimus-eluting stent (Xience or Promus)
Use everolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Xience
  • Promus
Drug: 6-month clopidogrel therapy
Use clopidogrel for 6 months
Other Name: Plavix
Active Comparator: S6
Sirolimus-eluting stent 6-month clopidogrel therapy
 Device: Sirolimus-eluting stent (Cypher)
Use sirolimus-eluting stent in the treatment of coronary stenosis
Other Name: Cypher
Drug: 6-month clopidogrel therapy
Use clopidogrel for 6 months
Other Name: Plavix
Experimental: E12
Everolimus-eluting stent 12-month clopidogrel therapy
 Device: Everolimus-eluting stent (Xience or Promus)
Use everolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Xience
  • Promus
Drug: 12-month clopidogrel therapy
Use clopidogrel for 12 months
Other Name: Plavix
Active Comparator: S12
Sirolimus-eluting stent 12-month clopidogrel therapy
 Device: Sirolimus-eluting stent (Cypher)
Use sirolimus-eluting stent in the treatment of coronary stenosis
Other Name: Cypher
Drug: 12-month clopidogrel therapy
Use clopidogrel for 12 months
Other Name: Plavix

  Eligibility

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

General Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  3. Subject must have significant coronary artery stenosis (>50% by visual estimate)
  4. 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 coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
  5. Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.

Angiographically Inclusion Criteria

  1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
  2. Target lesion(s) must be amenable for percutaneous coronary intervention

General Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
  2. Systemic (intravenous) Sirolimus, everolimus use within 12 months.
  3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  6. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  7. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
  8. 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).
  9. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  10. Patients who have received any stent implantation in the target vessel prior to enrollment.
  11. Patients with LVEF<25% or those with cardiogenic shock
  12. Patients with myocardial infarction within 72 hours
  13. Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
  14. Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).

Angiographic Exclusion Criteria

  1. Patients with significant left main coronary artery stenosis
  2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
  3. Target lesions with chronic total occlusion
  4. True bifurcation lesions requiring two stents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698607

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, 28 Yongon Dong, Jongro Gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Abbott
Boston Scientific Corporation
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
Study Chair: Yangsoo Jang, MD, PhD Yonsei University Medical Center
Study Chair: Jung-Han Yoon, MD, PhD Yonsei Univercity Wonju hospital
Study Chair: Ahn Tae-Hoon, MD, PhD Gachon Kil Medical Center
Study Chair: Hyun-Cheol Kwon, MD, PhD Samsung Medical Center
Study Chair: In-Ho Chae, MD, PhD Seoul National University Bundang Hospital
Principal Investigator: Young-Jin Choi, MD, PhD Hallym University Medical Center
Principal Investigator: Kyoo-Rok Han, MD, PhD Kandong Sacred heart Hospital
Principal Investigator: Si-Hoon Park, MD, PhD Ewha Women's University Hospital
Principal Investigator: Myeong-Ho Chung, MD, PhD Chonnam National University Hospital
Principal Investigator: Hyuk-Moon Kwon, MD, PhD Yonsei University
Principal Investigator: Dong-Woon Chun, MD, PhD National Health Insurance Corporation Ilsan Hospital
Principal Investigator: Byung-Ok Kim, MD, PhD Inje University Sanggye Hospital
Principal Investigator: Do-Sun Lim, MD, PhD Korea University Anam Hospital
Principal Investigator: Taek-Jong Hong, MD, PhD Pusan National University Hospital
Principal Investigator: Woo-Young Chung, MD, PhD Borame Hospital
Principal Investigator: Jae-Hun Chung, MD, PhD Kangnam Sacred Heart 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: NCT00698607     History of Changes
Other Study ID Numbers: EXCELLENT
Study First Received: June 15, 2008
Last Updated: June 28, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Everolimus
Sirolimus
drug eluting stent
Clopidogrel

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

ClinicalTrials.gov processed this record on May 23, 2013