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

Sponsored by:	The Hospital District of Satakunta
Information provided by:	The Hospital District of Satakunta
ClinicalTrials.gov Identifier:	NCT00819923

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 III

Drug Information available for: Everolimus

U.S. FDA Resources

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

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 18 months of follow-up. [ Time Frame: 18 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 ]

Estimated Enrollment:	1050
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving bio-active stent during the intervention	Device: Percutaneous coronary intervention Intra-coronary stenting
2: Active Comparator Patients receiving everolimus-eluting stent during the intervention	Device: Percutaneous coronary intervention Intra-coronary stenting

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 1050 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 18 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

Contacts

Contact: Pasi P Karjalainen, MD, PhD	+ 358 2 627 7755	pasi.karjalainen@satshp.fi
Contact: Antti Ylitalo, MD, PhD	+ 358 2 627 7755	antti.ylitalo@satshp.fi

Locations

Finland
Satakunta Central Hospital	Recruiting
Pori, Finland, 28500
Contact: Pasi P Karjalainen, MD, PhD +358 2 627 7755 pasi.karjalainen@satshp.fi
Contact: Antti Ylitalo, MD, PhD +358 2 627 7755 antti.ylitalo@satshp.fi
Principal Investigator: Pasi P Karjalainen, MD, PhD
Sub-Investigator: Antti Ylitalo, MD, PhD
Sub-Investigator: Jussi Mikkelsson, MD, PhD
Oulu University Hospital	Recruiting
Oulu, Finland, 90100
Principal Investigator: Matti Niemala, MD, PhD
Sub-Investigator: Kari Kervinen, MD, PhD
Sub-Investigator: Hannu Romppanen, MD, PhD
Turku University Hospital	Recruiting
Turku, Finland
Principal Investigator: Juhani KE Airaksinen, Professor
Sub-Investigator: Mikko Pietila, MD, PhD
Keski-Pohjanmaan Keskusairaala	Recruiting
Kokkola, Finland
Principal Investigator: Jussi Sia, MD
Jyvaskyla Central Hospital	Recruiting
Jyvaskyla, Finland
Principal Investigator: Kai Nyman, MD
Sub-Investigator: Seija Paakkinen, MD
Sub-Investigator: Pertti Koivunen, MD

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

Responsible Party:	Department of cardiology, Satakunta Central Hospital ( Pasi Karjalainen, MD, PhD )
Study ID Numbers:	SA-003
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819923
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

Study placed in the following topic categories:

Everolimus
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Ischemia
Thrombosis

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immunologic Factors
Syndrome

Physiological Effects of Drugs
Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009