Acute Myocardial InfarctionPhase 4DEBATERNCT00986050
Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
A Phase 4 study testing Abciximab, bare metal stent prokinetic, chrono, skylor or bluemedical and drug eluting stent (sirolimus eluting) - CYPHER stent in people with Acute Myocardial Infarction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Abciximab, bare metal stent prokinetic, chrono, skylor or bluemedical and drug eluting stent (sirolimus eluting) - CYPHER stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 907 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2006to Jul 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- STEMI ≤ 12 hours (or STEMI equivalent).
- No contra - indications for primary PCI.
- No contra - indications for abciximab.
- Informed consent from the patient.
Who cannot join
- Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI.
- Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident < 6 months, major surgery/trauma < 6 months, platelet count < 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR >1.5, severe hepatic dysfunction
- Contra - indications for clopidogrel:
- Severe liver dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding.
- Thrombolytic therapy < 24 hours.
- Therapy with GPI < 24 hours.
Show all 9Show fewer
- Anticoagulation therapy.
- Co - morbid conditions with a predictable fatal outcome in the short run.
- No informed consent: refusal, coma, artificial respiration, impaired mentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study
The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Read the detailed description
In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice.
The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI.
GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation.
The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Abciximab, bare metal stent prokinetic, chrono, skylor or bluemedical, drug eluting stent (sirolimus eluting) - CYPHER stent
- Keywords
- STEMI, DES, BMS, abciximab
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbciximabDrug
Also called reopro
Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
bare metal stent prokinetic, chrono, skylor or bluemedicalDevice
Also called operator-dependent: prokinetic, chrono, skylor, bluemedical
bare metal stent in culprit artery in acute myocardial infarction
drug eluting stent (sirolimus eluting) - CYPHER stentDevice
Also called CYPHER stent
stent implantation in culprit artery in acute myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Bare metal stent (BMS) | Active comparator | Not described Receives: Device: bare metal stent prokinetic, chrono, skylor or bluemedical |
| Drug eluting stent (DES) | Active comparator | Not described Receives: Device: drug eluting stent (sirolimus eluting) - CYPHER stent |
| Abciximab | Active comparator | Not described Receives: Drug: Abciximab |
| No abciximab | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel failure
Measured: 30 days and one year
Secondary outcomes (1)
Major adverse cardiac and cerebral adverse events ( MACCE)
Measured: 30 days and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Compusense Oegstgeest ( electronic randomization and CRF), CATHREINE ( data monitoring)
- Investigators
- Rolf Michels, Principal investigator, Catharina Ziekenhuis EindhovenInge Wijnbergen, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986050
- Sponsor's protocol ID
- CATHREINE-DEBATER 2006
- Acronym
- DEBATER
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2009
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
PubMed 15769784Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
PubMed 11419426Schomig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Berger PB, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel. Eur Heart J. 2005 Jul;26(14):1379-84. doi: 10.1093/eurheartj/ehi174. Epub 2005 Feb 25.
PubMed 15734767Wijnbergen I, Helmes H, Tijssen J, Brueren G, Peels K, van Dantzig JM, Van' t Veer M, Koolen JJ, Pijls NH, Michels R. Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study. JACC Cardiovasc Interv. 2012 Mar;5(3):313-22. doi: 10.1016/j.jcin.2011.11.009.
PubMed 22440498
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study
- ClinicalTrials.gov ID
- NCT00986050
- Acronym / sponsor ID
- DEBATER / CATHREINE-DEBATER 2006
- Conditions
- Acute Myocardial Infarction
- Keywords
- STEMI, DES, BMS, abciximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Compusense Oegstgeest ( electronic randomization and CRF), CATHREINE ( data monitoring)
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Sep 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 DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Detailed description
In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice.
The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI.
GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation.
The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bare metal stent (BMS) | Active comparator | Device: bare metal stent prokinetic, chrono, skylor or bluemedical |
| Drug eluting stent (DES) | Active comparator | Device: drug eluting stent (sirolimus eluting) - CYPHER stent |
| Abciximab | Active comparator | Drug: Abciximab |
| No abciximab | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- STEMI ≤ 12 hours (or STEMI equivalent).
- No contra - indications for primary PCI.
- No contra - indications for abciximab.
- Informed consent from the patient.
Key exclusion criteria (9 listed)
- Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI.
- Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident < 6 months, major surgery/trauma < 6 months, platelet count < 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR >1.5, severe hepatic dysfunction
- Contra - indications for clopidogrel:
- Co - morbid conditions with a predictable fatal outcome in the short run.
- No informed consent: refusal, coma, artificial respiration, impaired mentation.
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 |
|---|---|---|
| AbciximabAlso: reoproAbciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI. | Drug | Abciximab |
| bare metal stent prokinetic, chrono, skylor or bluemedicalAlso: operator-dependent: prokinetic, chrono, skylor, bluemedicalbare metal stent in culprit artery in acute myocardial infarction | Device | Bare metal stent (BMS) |
| drug eluting stent (sirolimus eluting) - CYPHER stentAlso: CYPHER stentstent implantation in culprit artery in acute myocardial infarction | Device | Drug eluting stent (DES) |
Primary outcome
target vessel failure
Time frame: 30 days and one year
1 secondary outcome
Major adverse cardiac and cerebral adverse events ( MACCE)
Time frame: 30 days and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
- Background: PubMed 15769784Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
- Background: PubMed 11419426Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
- Background: PubMed 15734767Schomig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Berger PB, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel. Eur Heart J. 2005 Jul;26(14):1379-84. doi: 10.1093/eurheartj/ehi174. Epub 2005 Feb 25.
- Derived from this study: PubMed 22440498Wijnbergen I, Helmes H, Tijssen J, Brueren G, Peels K, van Dantzig JM, Van' t Veer M, Koolen JJ, Pijls NH, Michels R. Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study. JACC Cardiovasc Interv. 2012 Mar;5(3):313-22. doi: 10.1016/j.jcin.2011.11.009.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Rolf Michels principal investigator
Catharina Ziekenhuis Eindhoven
Inge Wijnbergen principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abciximab, bare metal stent prokinetic, chrono, skylor or bluemedical and drug eluting stent (sirolimus eluting) - CYPHER stent in people with Acute Myocardial Infarction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
target vessel failure (time frame: 30 days and one year). 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 NCT00986050, which also lists 4 linked publications.
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 26 Jul 2011.