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

Phase 3UnknownNCT00819923

The Hospital District of Satakunta825 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

825

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous coronary interventionDEVICE

Intra-coronary stenting

Percutaneous coronary interventionDEVICE

Intra-coronary stenting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Helsinki University Hospital

Helsinki, Finland

Jyvaskyla Central Hospital

Jyväskylä, Finland

Keski-Pohjanmaan Keskusairaala

Kokkola, Finland

Oulu University Hospital

Oulu, Finland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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