Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

907 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

NCT01087723

Acute Coronary Syndrome

COMPLETED PHASE3

Drug-eluting Balloon in Acute Myocardial Infarction

NCT00856765

Coronary Artery Disease Atherosclerosis Thrombosis +1 more

COMPLETED PHASE2/PHASE3

Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)

NCT00426751

Infarction, Myocardial

COMPLETED PHASE3

Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome

NCT00373451

Myocardial Infarction Coronary Disease

COMPLETED PHASE4

Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction

NCT00712101

ST-elevation Myocardial Infarction

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bare metal stent (BMS)

Group Type ACTIVE_COMPARATOR

bare metal stent prokinetic, chrono, skylor or bluemedical

Intervention Type DEVICE

bare metal stent in culprit artery in acute myocardial infarction

Drug eluting stent (DES)

Group Type ACTIVE_COMPARATOR

drug eluting stent (sirolimus eluting) - CYPHER stent

Intervention Type DEVICE

stent implantation in culprit artery in acute myocardial infarction

Abciximab

Group Type ACTIVE_COMPARATOR

Abciximab

Intervention Type DRUG

Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.

No abciximab

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abciximab

Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.

Intervention Type DRUG

bare metal stent prokinetic, chrono, skylor or bluemedical

bare metal stent in culprit artery in acute myocardial infarction

Intervention Type DEVICE

drug eluting stent (sirolimus eluting) - CYPHER stent

stent implantation in culprit artery in acute myocardial infarction

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

reopro operator-dependent: prokinetic, chrono, skylor, bluemedical CYPHER stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* STEMI ≤ 12 hours (or STEMI equivalent).
* No contra - indications for primary PCI.
* No contra - indications for abciximab.
* Informed consent from the patient.

Exclusion Criteria

* 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.
* Anticoagulation therapy.
* Co - morbid conditions with a predictable fatal outcome in the short run.
* No informed consent: refusal, coma, artificial respiration, impaired mentation.

Eligible Sex

ALL

Accepts Healthy Volunteers

No