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

Phase 3

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Percutaneous coronary intervention

• Registration Number: NCT00819923
• Lead Sponsor: The Hospital District of Satakunta

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05
• Primary Completion: 2013-05
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 825

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Percutaneous coronary intervention	Patients receiving bio-active stent during the intervention
2	Percutaneous coronary intervention	Patients receiving everolimus-eluting stent during the intervention

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
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.	5 years

Trial Locations

Locations (6)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Keski-Pohjanmaan Keskusairaala; 🇫🇮 Kokkola, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Jyvaskyla Central Hospital; 🇫🇮 Jyvaskyla, Finland