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

May 4, 2011 updated by: The Hospital District of Satakunta

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Jyvaskyla, Finland
        • Jyväskylä Central Hospital
      • Kokkola, Finland
        • Keski-Pohjanmaan Keskusairaala
      • Oulu, Finland, 90100
        • Oulu University Hospital
      • Pori, Finland, 28500
        • Satakunta Central Hospital
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients receiving bio-active stent during the intervention
Device: Percutaneous coronary intervention
Intra-coronary stenting
Other Names:
  • Promus (Boston,USA)
  • Xience-V (abbott, Usa)
Active Comparator: 2
Patients receiving everolimus-eluting stent during the intervention
Device: Percutaneous coronary intervention
Intra-coronary stenting
Other Names:
  • Promus (Boston,USA)
  • Xience-V (abbott, Usa)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital District of Satakunta

Investigators

  • 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
  • Principal Investigator: Juhani KE Airaksinen, Professor, Turku University Hospital, Turku, Finland
  • Principal Investigator: Otto Hess, Professor, Bern University Hospital, Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2011

Last Update Submitted That Met QC Criteria

May 4, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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