Overview

This trial is active, not recruiting.

Condition acute coronary syndrome
Treatments percutaneous coronary intervention
Phase phase 3
Sponsor The Hospital District of Satakunta
Start date November 2008
End date May 2013
Trial size 825 participants
Trial identifier NCT00819923, SA-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Patients receiving bio-active stent during the intervention
percutaneous coronary intervention TITAN-2 stent,
Intra-coronary stenting
(Active Comparator)
Patients receiving everolimus-eluting stent during the intervention
percutaneous coronary intervention Promus (Boston,USA)
Intra-coronary stenting

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.
time frame: 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.
time frame: 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by The Hospital District of Satakunta.