Myocardial InfarctionPhase 4NCT00354406
Efficacy Study on Early Versus Late Abciximab Administration During Primary Coronary Angioplasty
A Phase 4 study testing abciximab in people with Myocardial Infarction, run by University of Pisa at 1 site in Italy.
Trial summary
Abciximab has been demonstrated to improve outcome when administered during primary angioplasty in patients with acute myocardial infarction. The Primary Objective of the study is to demonstrate that early (before transportation form remote hospital to the cath lab) abciximab administration during acute myocardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 110 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2006to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 6 hours prior to randomization, and ST segment elevation ≥ 2mm or new left bundle branch block
- Absence of contraindications to Abciximab (for details cf. below section)
- Written informed consent
Who cannot join
- Low-risk (ST elevation in ≤2 leads) inferior AMI
- Previous infarction in the same area (assessed by ECG)
- PCI in the 2 weeks prior to AMI
- Know hypersensitivity to abciximab
- Active internal bleeding
- History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit
Show all 16Show fewer
- Head or spine surgery or trauma in the previous 2 months
- Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
- Administration of oral anticoagulants within seven days unless prothrombin time is <1.2 times control
- Bleeding diathesis or severe uncontrolled arterial hypertension
- Thrombocytopenia (<100 000 cells/mL)
- Recent (within six weeks) major surgery or trauma
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Severe renal or liver failure
- Allergy to aspirin
- Contraindication to MRI examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing the Efficacy on Myocardial Infarct Size Reduction of Early vs. Late Abciximab Administration During Primary Percutaneous Coronary Angioplasty
Abciximab has been demonstrated to improve outcome when administered during primary angioplasty in patients with acute myocardial infarction. The Primary Objective of the study is to demonstrate that early (before transportation form remote hospital to the cath lab) abciximab administration during acute myocardial infarction reduces infarct size as compared with late (just prior to PCI) abciximab administration, as measured by delayed enhancement magnetic resonance (MR) at 6 months.
Read the detailed description
Strategies directed at improving myocardial perfusion or viability in the setting of acute myocardial infarction (AMI) are currently suboptimal. The consequences of microvascular damage, as assessed by the TIMI myocardial perfusion (TMP) grade or by cardiac magnetic resonance imaging (MR), are serious and affect survival after AMI. Because the size of the infarct is an important predictor of prognosis, precise determination of infarct size allows risk stratification of patients after AMI.
First-pass MR perfusion studies recently developed provide quantification of the absolute measure of myocardial blood flow as well as direct visualization of myocardial perfusion abnormalities, such as areas of "no-reflow". The hyperenhancement technique (Delayed enhancement) identifies viable and nonviable myocardium as well as no-reflow areas.
A recent pilot study showed that infarct size measured by scintigraphy at 7 days was 23% vs 14% when abciximab was administered in the cath lab vs emergency room, with a reduction in infarct size of 40%.
The present study will be conducted at the Cardiothoracic Department of the University of Pisa together with the Institute of Clinical Physiology (CNR) and two other Cath Labs of the West of Tuscany. Each Cath Lab will treat patients enrolled in peripheral hospitals referring the patients for primary PCI.
The primary objective of the study is to demonstrate that early abciximab administration (before transfer) as compared with late abciximab administration (in the Cath Lab) reduces infarct size as measured by delayed hyperenhancement imaging at 6 months.
The major secondary objectives of this substudy are to demonstrate that early abciximab administration:
- Improves angiographic TMP grade and cTFC compared with primary PCI group, immediately after PCI.
- Reduces the extension of no-reflow areas, as assessed by DE-MRI before discharge.
- Reduces the extension of microvasculature damage as assessed by fist-pass perfusion study by MRI before discharge.
- Improves regional wall motion and left ventricular ejection fraction (LVEF) as measured by cine MR and 2D echocardiography at 6 months
- Reduces the occurrence of LV remodeling at 6 month follow up.
- Conditions
- Myocardial Infarction
- Being tested
- abciximab
- Keywords
- Abciximab, Magnetic Resonance Imaging, Percutaneous Transluminal Coronary Angioplasty
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abciximabDrug
standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients in Arm A (Early abciximab arm) will receive abciximab at time of STEMI diagnosis, before transfer to the Cath Lab to undergo primary angioplasty. Receives: Drug: abciximab |
| B | Active comparator | Patients in Arm B (Late abciximab arm) will receive abciximab at time of primary angioplasty, directly in the Cath Lab. Receives: Drug: abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
infarct size (% of left ventricular mass) as measured by delayed hyperenhancement magnetic resonance imaging at 6 months
Measured: at 6 months after myocardial infarction
Secondary outcomes (5)
Angiographic TIMI Myocardial Perfusion grade and corrected TIMI frame count, assessed immediately after PCI.
Measured: final angiography at the end of PCI
Extension of no-reflow areas (% of left ventricular mass), as assessed by delayed enhancement-MRI before hospital discharge.
Measured: At day 4-5 after myocardial infarction.
Extension of microvasculature damage (% of left ventricular mass), as assessed by fist-pass perfusion study by MRI before hospital discharge.
Measured: At day 4-5 after myocardial infarction
Regional wall motion and left ventricular ejection fraction, as measured by cine MRI and 2D echocardiography at 6 months
Measured: at 6 months after myocardial infarction
Rate of left ventricular remodeling (increase in end-diastolic volume >20%), as measured by cine MRI and 2D echocardiography at 6 months
Measured: at 6 months after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2008
- Study completionDec 2008
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 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Prof. Anna Sonia Petronio, University of Pisa
- Investigators
- Anna S Petronio, MD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354406
- Sponsor's protocol ID
- UP-DCT-200601
- Status last verified
- Nov 2011
- First submitted
- 19 Jul 2006
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Saadi N, Nagel E, Gross M, Schnackenburg B, Paetsch I, Klein C, Fleck E. Improvement of myocardial perfusion reserve early after coronary intervention: assessment with cardiac magnetic resonance imaging. J Am Coll Cardiol. 2000 Nov 1;36(5):1557-64. doi: 10.1016/s0735-1097(00)00914-1.
PubMed 11079658
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Efficacy on Myocardial Infarct Size Reduction of Early vs. Late Abciximab Administration During Primary Percutaneous Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT00354406
- Acronym / sponsor ID
- UP-DCT-200601
- Conditions
- Myocardial Infarction
- Keywords
- Abciximab, Magnetic Resonance Imaging, Percutaneous Transluminal Coronary Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Apr 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Jul 2006 (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.
Abciximab has been demonstrated to improve outcome when administered during primary angioplasty in patients with acute myocardial infarction. The Primary Objective of the study is to demonstrate that early (before transportation form remote hospital to the cath lab) abciximab administration during acute myocardial infarction reduces infarct size as compared with late (just prior to PCI) abciximab administration, as measured by delayed enhancement magnetic resonance (MR) at 6 months.
Detailed description
Strategies directed at improving myocardial perfusion or viability in the setting of acute myocardial infarction (AMI) are currently suboptimal. The consequences of microvascular damage, as assessed by the TIMI myocardial perfusion (TMP) grade or by cardiac magnetic resonance imaging (MR), are serious and affect survival after AMI. Because the size of the infarct is an important predictor of prognosis, precise determination of infarct size allows risk stratification of patients after AMI.
First-pass MR perfusion studies recently developed provide quantification of the absolute measure of myocardial blood flow as well as direct visualization of myocardial perfusion abnormalities, such as areas of "no-reflow". The hyperenhancement technique (Delayed enhancement) identifies viable and nonviable myocardium as well as no-reflow areas.
A recent pilot study showed that infarct size measured by scintigraphy at 7 days was 23% vs 14% when abciximab was administered in the cath lab vs emergency room, with a reduction in infarct size of 40%.
The present study will be conducted at the Cardiothoracic Department of the University of Pisa together with the Institute of Clinical Physiology (CNR) and two other Cath Labs of the West of Tuscany. Each Cath Lab will treat patients enrolled in peripheral hospitals referring the patients for primary PCI.
The primary objective of the study is to demonstrate that early abciximab administration (before transfer) as compared with late abciximab administration (in the Cath Lab) reduces infarct size as measured by delayed hyperenhancement imaging at 6 months.
The major secondary objectives of this substudy are to demonstrate that early abciximab administration:
- Improves angiographic TMP grade and cTFC compared with primary PCI group, immediately after PCI.
- Reduces the extension of no-reflow areas, as assessed by DE-MRI before discharge.
- Reduces the extension of microvasculature damage as assessed by fist-pass perfusion study by MRI before discharge.
- Improves regional wall motion and left ventricular ejection fraction (LVEF) as measured by cine MR and 2D echocardiography at 6 months
- Reduces the occurrence of LV remodeling at 6 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: abciximabPatients in Arm A (Early abciximab arm) will receive abciximab at time of STEMI diagnosis, before transfer to the Cath Lab to undergo primary angioplasty. |
| B | Active comparator | Drug: abciximabPatients in Arm B (Late abciximab arm) will receive abciximab at time of primary angioplasty, directly in the Cath Lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 6 hours prior to randomization, and ST segment elevation ≥ 2mm or new left bundle branch block
- Absence of contraindications to Abciximab (for details cf. below section)
- Written informed consent
Key exclusion criteria (16 listed)
- Low-risk (ST elevation in ≤2 leads) inferior AMI
- Previous infarction in the same area (assessed by ECG)
- PCI in the 2 weeks prior to AMI
- Know hypersensitivity to abciximab
- Active internal bleeding
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 |
|---|---|---|
| abciximabstandard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B. | Drug | A, B |
Primary outcome
infarct size (% of left ventricular mass) as measured by delayed hyperenhancement magnetic resonance imaging at 6 months
Time frame: at 6 months after myocardial infarction
5 secondary outcomes
Angiographic TIMI Myocardial Perfusion grade and corrected TIMI frame count, assessed immediately after PCI.
Time frame: final angiography at the end of PCI
Extension of no-reflow areas (% of left ventricular mass), as assessed by delayed enhancement-MRI before hospital discharge.
Time frame: At day 4-5 after myocardial infarction.
Extension of microvasculature damage (% of left ventricular mass), as assessed by fist-pass perfusion study by MRI before hospital discharge.
Time frame: At day 4-5 after myocardial infarction
Regional wall motion and left ventricular ejection fraction, as measured by cine MRI and 2D echocardiography at 6 months
Time frame: at 6 months after myocardial infarction
Rate of left ventricular remodeling (increase in end-diastolic volume >20%), as measured by cine MRI and 2D echocardiography at 6 months
Time frame: at 6 months after myocardial infarction
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 16 Nov 2011.
- Background: PubMed 11079658Al-Saadi N, Nagel E, Gross M, Schnackenburg B, Paetsch I, Klein C, Fleck E. Improvement of myocardial perfusion reserve early after coronary intervention: assessment with cardiac magnetic resonance imaging. J Am Coll Cardiol. 2000 Nov 1;36(5):1557-64. doi: 10.1016/s0735-1097(00)00914-1.
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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.
Anna S Petronio, MD principal investigator
University of Pisa
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 in people with Myocardial Infarction, run by University of Pisa at 1 site 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 3 inclusion and 16 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 16 Nov 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 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 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?
infarct size (% of left ventricular mass) as measured by delayed hyperenhancement magnetic resonance imaging at 6 months (time frame: at 6 months after myocardial infarction). 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 NCT00354406, 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 16 Nov 2011.