Clinical trial NCT00819923: Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
Official title: Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Titanium
everolimus
drug eluting stent
stent thrombosis
restenosis
percutaneous coronary intervention
acute coronary syndrome
Lead sponsor: The Hospital District of Satakunta
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyvaskyla
country: Finland
facility: Jyvaskyla Central Hospital
city: Kokkola
country: Finland
facility: Keski-Pohjanmaan Keskusairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Satakunta Central Hospital, Pori, Finland
name: Pasi P Karjalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Satakunta Central Hospital, Pori, Finland
name: Antti Ylitalo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Matti Niemela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital, Turku, Finland
name: Juhani KE Airaksinen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University Hospital, Bern, Switzerland
name: Otto Hess, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.