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

Acute Coronary Syndrome Clinical Trial

— BASE-ACS  

Official title:

Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00819923
• Other study ID #: SA-003
• Status: Unknown status
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: May 4, 2011
• Start date: November 2008
• Est. completion date: December 2014

Study information

• Verified date: May 2011
• Source: The Hospital District of Satakunta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 825
• Est. completion date: December 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• Percutaneous coronary intervention
Intra-coronary stenting
• Percutaneous coronary intervention
Intra-coronary stenting

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Jyvaskyla Central Hospital	Jyvaskyla
Finland	Keski-Pohjanmaan Keskusairaala	Kokkola
Finland	Oulu University Hospital	Oulu
Finland	Satakunta Central Hospital	Pori
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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