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Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS)

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Percutaneous coronary intervention

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Titanium, everolimus, drug eluting stent, stent thrombosis, restenosis, percutaneous coronary intervention, acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Hospital
Jyvaskyla Central Hospital
Keski-Pohjanmaan Keskusairaala
Oulu University Hospital
Satakunta Central Hospital
Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Patients receiving bio-active stent during the intervention

Patients receiving everolimus-eluting stent during the intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00819923

First Posted

January 8, 2009

Last Updated

May 4, 2011

Sponsor

The Hospital District of Satakunta

1. Study Identification

Unique Protocol Identification Number

NCT00819923

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2008 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Hospital District of Satakunta

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Titanium, everolimus, drug eluting stent, stent thrombosis, restenosis, percutaneous coronary intervention, acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

825 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients receiving bio-active stent during the intervention

Arm Title

Arm Type

Active Comparator

Arm Description

Patients receiving everolimus-eluting stent during the intervention

Intervention Type

Device

Intervention Name(s)

Percutaneous coronary intervention

Other Intervention Name(s)

TITAN-2 stent,, Hexacath, France

Intervention Description

Intra-coronary stenting

Intervention Type

Device

Intervention Name(s)

Percutaneous coronary intervention

Other Intervention Name(s)

Promus (Boston,USA), Xience-V (abbott, Usa)

Intervention Description

Intra-coronary stenting

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: