Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT00819923
First received: January 8, 2009
Last updated: May 4, 2011
Last verified: May 2011

January 8, 2009
May 4, 2011
November 2008
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 18 months of follow-up. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00819923 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Device: Percutaneous coronary intervention
    Intra-coronary stenting
    Other Names:
    • TITAN-2 stent,
    • Hexacath, France
  • Device: Percutaneous coronary intervention
    Intra-coronary stenting
    Other Names:
    • Promus (Boston,USA)
    • Xience-V (abbott, Usa)
  • Experimental: 1
    Patients receiving bio-active stent during the intervention
    Intervention: Device: Percutaneous coronary intervention
  • Active Comparator: 2
    Patients receiving everolimus-eluting stent during the intervention
    Intervention: Device: Percutaneous coronary intervention
Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31. Erratum in: Int J Cardiovasc Imaging. 2013 Dec;29(8):1915. Kiviniemi, Tuomas O [added]; Lehtinen, Tuomas [added]; Nammas, Wail [added]; Ylitalo, Antti [added]; Saraste, Antti [added]; Mikkelsson, Jussi [added]; Pietila, Mikko [added]; Biancari, Fausto [added]; Airaksinen, Juhani K E [added].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
825
December 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00819923
SA-003
Yes
Pasi Karjalainen, MD, PhD, Department of cardiology, Satakunta Central Hospital
The Hospital District of Satakunta
Not Provided
Principal Investigator: Pasi P Karjalainen, MD, PhD Satakunta Central Hospital, Pori, Finland
Principal Investigator: Antti Ylitalo, MD, PhD Satakunta Central Hospital, Pori, Finland
Principal Investigator: Matti Niemela, MD, PhD Oulu University Hospital, Oulu, Finland
Principal Investigator: Juhani KE Airaksinen, Professor Turku University Hospital, Turku, Finland
Principal Investigator: Otto Hess, Professor Bern University Hospital, Bern, Switzerland
The Hospital District of Satakunta
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP