Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
This trial is active, not recruiting.
|Condition||acute coronary syndrome|
|Treatments||percutaneous coronary intervention|
|Sponsor||The Hospital District of Satakunta|
|Start date||November 2008|
|End date||May 2013|
|Trial size||825 participants|
|Trial identifier||NCT00819923, SA-003|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Helsinki, Finland||Helsinki University Hospital||no longer recruiting|
|Jyvaskyla, Finland||Jyvaskyla Central Hospital||no longer recruiting|
|Kokkola, Finland||Keski-Pohjanmaan Keskusairaala||no longer recruiting|
|Oulu, Finland||Oulu University Hospital||no longer recruiting|
|Pori, Finland||Satakunta Central Hospital||no longer recruiting|
|Turku, Finland||Turku University Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
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
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
Male or female participants at least 18 years old.
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
|Official title||Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)|
|Principal investigator||Pasi P Karjalainen, MD, PhD|
|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.|
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