Acute Myocardial InfarctionPhase 3IC-CLEARLYNCT00894023
Intracoronary Abciximab With Clearway Catheter
A Phase 3 study testing Intracoronary bolus wtih ClearWay™RX catheter and IV abciximab in people with Acute Myocardial Infarction, run by Gennaro Sardella at 2 sites in Italy.
Trial summary
Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP) IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients, with thrombus, undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Intracoronary bolus wtih ClearWay™RX catheter and IV abciximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2009to Jun 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (men or women) at least 18 years of age
- STEMI: Presenting with ischemic chest discomfort > 20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND ST elevation > 1 mm (> 0.1 mV) in two contiguous limb leads OR > 2 mm (> 0.2 mV) in two contiguous precordial leads
- Must have signed the informed consent form prior to performance of study-related procedures
- Native dominant and proximal culprit vessel 2.5 mm in diameter
- Angiographically identifiable thrombus (presence of a filling defect within the coronary lumen surrounded by contrast medium observed in multiple projections, without calcium within the filling defect, or persistence of contrast medium within the coronary lumen)
- Pre-PCI Thrombus score (TS) ≥ 2 (angiographically apparent thrombus that is > ½ the vessel diameter)
- Pre-PCI TIMI flow grade of 0-2
Who cannot join
- Previous PCI of the IRA
- Previous myocardial infarction or coronary artery bypass grafting
- Cardiogenic shock
- Three vessel disease
- Left main disease
- Severe valvular heart disease
Show all 12Show fewer
- Rescue PCI (PCI following fibrinolytic administration)
- Facilitated PCI (PCI following fibrinolytic or GP IIb/IIIa inhibition)
- Contraindication to GP IIb/IIIa inhibitors such as excess bleeding risk or thrombocytopenia
- Current participation in another investigational trial
- Exclusion criteria for the MRI imaging include implanted pacemakers, defibrillators, or metallic intracranial implants, severe claustrophobia, BMI > 35 kg/m², atrial fibrillation or known not well controlled extrasystoles (bad images), or allergy to gadolinium-DTPA
- Enrolment of patients with an estimated glomerular filtration rate < 30 ml/min/1.73 m2 should be carefully evaluated considering the gadolinium chelate-associated risk of nephrogenic systemic fibrosis
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico of Modena
Modena, Italy, 41124
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, 00155
About this study
Official title: IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis
Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP) IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients, with thrombus, undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes.
Study design: Intracoronary Abciximab With Clearway Catheter trial is a randomized, open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of abciximab delivered using the ClearWay™RX catheter versus an intravenous bolus (IV) of abciximab for STEMI with angiographically visible thrombus (Thrombus Grade > 2). All patients in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per standard practice. A total of 150 patients will be randomized 1:1 to treatment of the culprit artery with IC abciximab (75 subjects) or IV abciximab (75 subjects) in addition to an infusion regimen of abciximab administered intravenously and initiated following PCI. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on Cardiac Magnetic Resonance (CMR). Clinical outcomes will be assessed for each subject through hospital discharge and at 30 day follow-up.
Read more
Sample size: The number of patients included in this study was based on the estimation of the sample size needed to identify a statistically significant difference of the primary end-points between the two groups. The investigators estimated that 75 patients would be required in each study group to have a power of 80% to detect an absolute difference in the infarct size resolution of 15% with a two-sided alpha value of 0.05.
Conclusion: The purpose of this study is to demonstrate that an IC bolus of abciximab delivered with the ClearWay™RX catheter added to a post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo when compared with an IV bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Intracoronary bolus wtih ClearWay™RX catheter, IV abciximab
- Keywords
- Patients with AMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary bolus wtih ClearWay™RX catheterDrug
Intracoronary bolus with Clearway catheter
IV abciximabDrug
IV abciximab + infusion
| Study group | Role | What they receive |
|---|---|---|
| Abciximab | Experimental | IC bolus of abciximab Receives: Drug: Intracoronary bolus wtih ClearWay™RX catheter |
| IV Abciximab | Active comparator | IV abciximab + infusion Receives: Drug: IV abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging
Measured: 24 months
Secondary outcomes (1)
Angiographic outcomes of lesion, flow, and myocardial perfusion using established and validated Quantitative Coronary Angiographic Methodology
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionJun 2011
Why it stopped: the study was stopped because the sample size was very difficult to achieve.
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gennaro Sardella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gennaro Sardella, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894023
- Sponsor's protocol ID
- SARD03
- Acronym
- IC-CLEARLY
- Status last verified
- Jan 2013
- First submitted
- 4 May 2009
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sardella G, Sangiorgi GM, Mancone M, Colantonio R, Donahue M, Politi L, Bucciarelli-Ducci C, Carbone I, Francone M, Ligabue G, Fiocchi F, Di Roma A, Benedetti G, Lucisano L, Stio RE, Agati L, Modena MG, Genuini I, Fedele F, Gibson M. A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationale. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):529-35. doi: 10.2459/JCM.0b013e3283341c1c.
PubMed 19918189
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis
- ClinicalTrials.gov ID
- NCT00894023
- Acronym / sponsor ID
- IC-CLEARLY / SARD03
- Conditions
- Acute Myocardial Infarction
- Keywords
- Patients with AMI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was stopped because the sample size was very difficult to achieve.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gennaro SardellaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 May 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.
Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP) IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients, with thrombus, undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes.
Study design: Intracoronary Abciximab With Clearway Catheter trial is a randomized, open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of abciximab delivered using the ClearWay™RX catheter versus an intravenous bolus (IV) of abciximab for STEMI with angiographically visible thrombus (Thrombus Grade > 2). All patients in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per standard practice. A total of 150 patients will be randomized 1:1 to treatment of the culprit artery with IC abciximab (75 subjects) or IV abciximab (75 subjects) in addition to an infusion regimen of abciximab administered intravenously and initiated following PCI. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on Cardiac Magnetic Resonance (CMR). Clinical outcomes will be assessed for each subject through hospital discharge and at 30 day follow-up.
Sample size: The number of patients included in this study was based on the estimation of the sample size needed to identify a statistically significant difference of the primary end-points between the two groups. The investigators estimated that 75 patients would be required in each study group to have a power of 80% to detect an absolute difference in the infarct size resolution of 15% with a two-sided alpha value of 0.05.
Conclusion: The purpose of this study is to demonstrate that an IC bolus of abciximab delivered with the ClearWay™RX catheter added to a post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo when compared with an IV bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abciximab | Experimental | Drug: Intracoronary bolus wtih ClearWay™RX catheterIC bolus of abciximab |
| IV Abciximab | Active comparator | Drug: IV abciximabIV abciximab + infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients (men or women) at least 18 years of age
- STEMI: Presenting with ischemic chest discomfort > 20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND ST elevation > 1 mm (> 0.1 mV) in two contiguous limb leads OR > 2 mm (> 0.2 mV) in two contiguous precordial leads
- Must have signed the informed consent form prior to performance of study-related procedures
- Native dominant and proximal culprit vessel 2.5 mm in diameter
- Angiographically identifiable thrombus (presence of a filling defect within the coronary lumen surrounded by contrast medium observed in multiple projections, without calcium within the filling defect, or persistence of contrast medium within the coronary lumen)
Key exclusion criteria (12 listed)
- Previous PCI of the IRA
- Previous myocardial infarction or coronary artery bypass grafting
- Cardiogenic shock
- Three vessel disease
- Left main disease
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 |
|---|---|---|
| Intracoronary bolus wtih ClearWay™RX catheterIntracoronary bolus with Clearway catheter | Drug | Abciximab |
| IV abciximabIV abciximab + infusion | Drug | IV Abciximab |
Primary outcome
Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging
Time frame: 24 months
1 secondary outcome
Angiographic outcomes of lesion, flow, and myocardial perfusion using established and validated Quantitative Coronary Angiographic Methodology
Time frame: 24 months
Results and safety
The study was stopped early (reason given: the study was stopped because the sample size was very difficult to achieve.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Derived from this study: PubMed 19918189Sardella G, Sangiorgi GM, Mancone M, Colantonio R, Donahue M, Politi L, Bucciarelli-Ducci C, Carbone I, Francone M, Ligabue G, Fiocchi F, Di Roma A, Benedetti G, Lucisano L, Stio RE, Agati L, Modena MG, Genuini I, Fedele F, Gibson M. A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationale. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):529-35. doi: 10.2459/JCM.0b013e3283341c1c.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Intracoronary bolus wtih ClearWay™RX catheter and IV abciximab in people with Acute Myocardial Infarction, run by Gennaro Sardella at 2 sites in Italy.
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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study was stopped early (reason given: the study was stopped because the sample size was very difficult to achieve.). 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?
Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging (time frame: 24 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 NCT00894023, 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 4 Jan 2013.