Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome

Brief Summary

Official Title: “Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)”

The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS) and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2013

Detailed Clinical Trial Description

The BASE-ACS trial is an academic study, which will be conceived and conducted as a multicenter (multi-country) study by experienced interventional cardiologists. This study is independent of commercial interests.

The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (Titan-2®) and everolimus-eluting stent (Xience V®, Promus®) in patients presenting with acute coronary syndrome.

A total of 850 patients will be included in the randomized study. The primary end point (MACE) is the composite of cardiac death, myocardial infarction and target lesion revascularization during 12 months of follow-up. Enrollment of patients will start in November 2008 and end in 2009.

Interventions Used in this Clinical Trial

  • Device: Percutaneous coronary intervention
    • Intra-coronary stenting
  • Device: Percutaneous coronary intervention
    • Intra-coronary stenting

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Patients receiving bio-active stent during the intervention
  • Active Comparator: 2
    • Patients receiving everolimus-eluting stent during the intervention

Outcome Measures for this Clinical Trial

Primary Measures

  • The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up.
    • Time Frame: 12 months
      Safety Issue?: Yes

Secondary Measures

  • All cause death, cardiac death, MI, stent thrombosis and TLR at 1, 6, 12 and 18 months, and at 2, 3, 4 and 5 years.
    • Time Frame: 5 years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • All patients presenting with acute coronary syndrome (unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction)and undergoing percutaneous coronary intervention
  • Written informed consent

Exclusion Criteria

  • Age < 18 years
  • Expected survival < 1 year
  • Allergy to aspirin, clopidogrel or ticlopidine
  • Allergy to heparins, glycoprotein IIb/IIIa inhibitors or bivalirudin
  • Allergy to everolimus
  • Active bleeding or significant increased risk of bleeding
  • Stent length longer than 28 mm needed
  • Stent diameter > 4.0 mm needed
  • Thrombolysis therapy
  • Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • The Hospital District of Satakunta
  • Provider of Information About this Clinical Study
    • Pasi Karjalainen, MD, PhD, Department of cardiology, Satakunta Central Hospital
  • Overall Official(s)
    • Pasi P Karjalainen, MD, PhD, Principal Investigator, Satakunta Central Hospital, Pori, Finland
    • Antti Ylitalo, MD, PhD, Principal Investigator, Satakunta Central Hospital, Pori, Finland
    • Matti Niemela, MD, PhD, Principal Investigator, Oulu University Hospital, Oulu, Finland
    • Juhani KE Airaksinen, Professor, Principal Investigator, Turku University Hospital, Turku, Finland
    • Otto Hess, Professor, Principal Investigator, Bern University Hospital, Bern, Switzerland

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00819923