Acute Coronary SyndromePhase 3BASE-ACSNCT00819923
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
A Phase 3 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta at 6 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 6 sitesFinland
- Study dates
- Nov 2008to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Helsinki University Hospital
Helsinki
Jyvaskyla Central Hospital
Jyväskylä
Keski-Pohjanmaan Keskusairaala
Kokkola
Oulu University Hospital
Oulu, 90100
Satakunta Central Hospital
Pori, 28500
Turku University Hospital
Turku
About this study
Official title: Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Percutaneous coronary intervention
- Keywords
- Titanium, everolimus, drug eluting stent, stent thrombosis, restenosis, percutaneous coronary intervention, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
Also called TITAN-2 stent,, Hexacath, France
Intra-coronary stenting
Percutaneous coronary interventionDevice
Also called Promus (Boston,USA), Xience-V (abbott, Usa)
Intra-coronary stenting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving bio-active stent during the intervention Receives: Device: Percutaneous coronary intervention |
| 2 | Active comparator | Patients receiving everolimus-eluting stent during the intervention Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Investigators
- Pasi P Karjalainen, MD, PhD, Principal investigator, Pori Central HospitalAntti Ylitalo, MD, PhD, Principal investigator, Pori Central HospitalMatti Niemela, MD, PhD, Principal investigator, Oulu University HospitalJuhani KE Airaksinen, Professor, Principal investigator, Turku University Hospital, Turku, FinlandOtto Hess, Professor, Principal investigator, Bern University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819923
- Sponsor's protocol ID
- SA-003
- Acronym
- BASE-ACS
- Status last verified
- May 2011
- First submitted
- 8 Jan 2009
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23996244
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)
- ClinicalTrials.gov ID
- NCT00819923
- Acronym / sponsor ID
- BASE-ACS / SA-003
- Conditions
- Acute Coronary Syndrome
- Keywords
- Titanium, everolimus, drug eluting stent, stent thrombosis, restenosis, percutaneous coronary intervention, acute coronary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 825 participants (actual)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Percutaneous coronary interventionPatients receiving bio-active stent during the intervention |
| 2 | Active comparator | Device: Percutaneous coronary interventionPatients receiving everolimus-eluting stent during the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionAlso: TITAN-2 stent,, Hexacath, FranceIntra-coronary stenting | Device | 1 |
| Percutaneous coronary interventionAlso: Promus (Boston,USA), Xience-V (abbott, Usa)Intra-coronary stenting | Device | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Derived from this study: PubMed 23996244Karjalainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi P Karjalainen, MD, PhD principal investigator
Pori Central Hospital
Antti Ylitalo, MD, PhD principal investigator
Pori Central Hospital
Matti Niemela, MD, PhD principal investigator
Oulu University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by The Hospital District of Satakunta at 6 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.