NCT00819923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
825

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

4.5 years

First QC Date

January 8, 2009

Last Update Submit

May 4, 2011

Conditions

Acute Coronary Syndrome

Keywords

Titaniumeverolimusdrug eluting stentstent thrombosisrestenosispercutaneous coronary interventionacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Patients receiving bio-active stent during the intervention

Device: Percutaneous coronary intervention

2

ACTIVE COMPARATOR

Patients receiving everolimus-eluting stent during the intervention

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionDEVICE

Intra-coronary stenting

Also known as: TITAN-2 stent,, Hexacath, France
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Helsinki University Hospital

Helsinki, Finland

Location

Jyvaskyla Central Hospital

Jyväskylä, Finland

Location

Keski-Pohjanmaan Keskusairaala

Kokkola, Finland

Location

Oulu University Hospital

Oulu, 90100, Finland

Location

Satakunta Central Hospital

Pori, 28500, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

  • Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31.

    PMID: 23996244DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Pasi P Karjalainen, MD, PhD

    Satakunta Central Hospital, Pori, Finland

    PRINCIPAL INVESTIGATOR

  • Antti Ylitalo, MD, PhD

    Satakunta Central Hospital, Pori, Finland

    PRINCIPAL INVESTIGATOR

  • Matti Niemela, MD, PhD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Juhani KE Airaksinen, Professor

    Turku University Hospital, Turku, Finland

    PRINCIPAL INVESTIGATOR

  • Otto Hess, Professor

    Bern University Hospital, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

November 1, 2008

Primary Completion

May 1, 2013

Study Completion

December 1, 2014

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

FI(6)