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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
 Device: Percutaneous coronary intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital District of Satakunta:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 825
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving bio-active stent during the intervention
 Device: Percutaneous coronary intervention
Intra-coronary stenting
Other Names:
  • TITAN-2 stent,
  • Hexacath, France
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)

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819923

Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Jyvaskyla Central Hospital
Jyvaskyla, Finland
Keski-Pohjanmaan Keskusairaala
Kokkola, Finland
Oulu University Hospital
Oulu, Finland, 90100
Satakunta Central Hospital
Pori, Finland, 28500
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
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, Oulu, Finland
Principal Investigator: Juhani KE Airaksinen, Professor Turku University Hospital, Turku, Finland
Principal Investigator: Otto Hess, Professor Bern University Hospital, Bern, Switzerland
  More Information

No publications provided

Responsible Party: Pasi Karjalainen, MD, PhD, Department of cardiology, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT00819923     History of Changes
Other Study ID Numbers: SA-003
Study First Received: January 8, 2009
Last Updated: May 4, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by The Hospital District of Satakunta:
Titanium
everolimus
drug eluting stent
stent thrombosis
 restenosis
percutaneous coronary intervention
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013