ST-Elevation Myocardial InfarctionCICERONCT00927615
Comparison of Intracoronary Versus Intravenous Abciximab in ST-segment Elevation Myocardial Infarction (CICERO)
A study testing abciximab in people with ST-Elevation Myocardial Infarction, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Apr 2011
- Phase
- Interventional
- 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
- a diagnosis of STEMI defined by
- chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
- time from onset of symptoms of less than 12 hours
- ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
Who cannot join
- rescue PCI after thrombolytic therapy
- need for emergency coronary artery bypass grafting
- presence of cardiogenic shock
- known existence of a life-threatening disease with a life expectancy of less than 6 months
- inability to provide informed consent
- contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Read the detailed description
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.
Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.
Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- abciximab
- Keywords
- myocardial infarction, glycoprotein IIb/IIIa, percutaneous coronary intervention, thrombus aspiration, myocardial perfusion
- Medical subject headings
- ST Elevation Myocardial Infarction, 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
0.25 mg/kg body weight (intracoronary)
abciximabDrug
Also called ReoPro
0.25 mg/kg body weight (intravenous)
| Study group | Role | What they receive |
|---|---|---|
| intracoronary abciximab | Experimental | intracoronary administration of abciximab (0.25 mg/kg body weight) Receives: Drug: abciximab |
| intravenous abciximab | Active comparator | intravenous administration of abciximab (0.25 mg/kg body weight) Receives: Drug: abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ST-segment resolution >70%
Measured: 30 to 60 minutes post-PCI
Secondary outcomes (7)
Bleeding complications
Measured: in-hospital
Thrombolysis In Myocardial Infarction (TIMI) flow
Measured: post-PCI
Myocardial Blush Grade (MBG)
Measured: post-PCI
Incidence of distal embolization
Measured: post-PCI
persistent residual ST-segment deviation
Measured: 30 to 60 minutes post-PCI
enzymatic infarct size
Measured: in-hospital
Major Adverse Cardiac Events (MACE)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionApr 2011 (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 ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Felix Zijlstra, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927615
- Sponsor's protocol ID
- 200807
- Acronym
- CICERO
- Status last verified
- Mar 2010
- First submitted
- 24 Jun 2009
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gu YL, Fokkema ML, Kampinga MA, de Smet BJ, Tan ES, van den Heuvel AF, Zijlstra F. Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration. Trials. 2009 Sep 28;10:90. doi: 10.1186/1745-6215-10-90.
PubMed 19785725
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
- ClinicalTrials.gov ID
- NCT00927615
- Acronym / sponsor ID
- CICERO / 200807
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- myocardial infarction, glycoprotein IIb/IIIa, percutaneous coronary intervention, thrombus aspiration, myocardial perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 534 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Apr 2011 (estimated)
- First posted
- 25 Jun 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 primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Detailed description
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.
Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.
Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracoronary abciximab | Experimental | Drug: abciximabintracoronary administration of abciximab (0.25 mg/kg body weight) |
| intravenous abciximab | Active comparator | Drug: abciximabintravenous administration of abciximab (0.25 mg/kg body weight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of STEMI defined by
- chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
- time from onset of symptoms of less than 12 hours
- ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
Key exclusion criteria (6 listed)
- rescue PCI after thrombolytic therapy
- need for emergency coronary artery bypass grafting
- presence of cardiogenic shock
- known existence of a life-threatening disease with a life expectancy of less than 6 months
- inability to provide informed consent
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: ReoPro0.25 mg/kg body weight (intracoronary) | Drug | intracoronary abciximab |
| abciximabAlso: ReoPro0.25 mg/kg body weight (intravenous) | Drug | intravenous abciximab |
Primary outcome
incidence of ST-segment resolution >70%
Time frame: 30 to 60 minutes post-PCI
7 secondary outcomes
Bleeding complications
Time frame: in-hospital
Thrombolysis In Myocardial Infarction (TIMI) flow
Time frame: post-PCI
Myocardial Blush Grade (MBG)
Time frame: post-PCI
Incidence of distal embolization
Time frame: post-PCI
persistent residual ST-segment deviation
Time frame: 30 to 60 minutes post-PCI
enzymatic infarct size
Time frame: in-hospital
Major Adverse Cardiac Events (MACE)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Derived from this study: PubMed 19785725Gu YL, Fokkema ML, Kampinga MA, de Smet BJ, Tan ES, van den Heuvel AF, Zijlstra F. Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration. Trials. 2009 Sep 28;10:90. doi: 10.1186/1745-6215-10-90.
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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.
Felix Zijlstra, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abciximab in people with ST-Elevation Myocardial Infarction, run by University Medical Center Groningen 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 6 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 8 Sep 2010. 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.
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?
incidence of ST-segment resolution >70% (time frame: 30 to 60 minutes post-PCI). 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 NCT00927615, 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 8 Sep 2010.