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The INFUSE - Anterior Myocardial Infarction (AMI) Study

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ClinicalTrials.gov Identifier: NCT00976521
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : July 8, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation

Study Description
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Brief Summary:

This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 US and European sites. Subjects who present with anterior ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the following arms:

  1. Local infusion of abciximab following thrombus aspiration
  2. Local infusion of abciximab and no thrombus aspiration
  3. No local infusion and thrombus aspiration
  4. No local infusion and no thrombus aspiration

In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.


Condition or disease Intervention/treatment Phase
Acute Anterior Myocardial Infarction Drug: Abciximab local infusion Other: No local infusion Procedure: Thrombus aspiration Not Applicable

Detailed Description:
The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary infusion of an abciximab bolus with or without thrombus aspiration prior to stent implantation, compared to no infusion with or without thrombus aspiration (standard of care), results in 1) reduced infarct size measured by cardiac MRI at 30 days (range -7 days/+14 days; i.e., between 23 and 44 days), 2) reduce microvascular obstruction (MVO) by cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days), 3) enhanced ST-segment resolution, 4) improved myocardial perfusion, 5) reduced thrombus burden and angiographic complications, and 6) no increase in major and minor bleeding.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction
Study Start Date : September 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Local infusion, thrombus aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
 Drug: Abciximab local infusion
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

Procedure: Thrombus aspiration
Thrombus aspiration
Experimental: Local infusion, no aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration
 Drug: Abciximab local infusion
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter
Active Comparator: No local infusion, thrombus aspiration
No local infusion of abciximab, thrombus aspiration.
 Other: No local infusion
Intervention without local infusion

Procedure: Thrombus aspiration
Thrombus aspiration
Active Comparator: No local infusion, no aspiration
No local infusion abciximab and no thrombus aspiration
 Other: No local infusion
Intervention without local infusion


Outcome Measures
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Primary Outcome Measures :
  1. Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion [ Time Frame: 30 Days Post Index Procedure ]
    The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.


Secondary Outcome Measures :
  1. Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration [ Time Frame: 30 Days ]
    The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • The subject must be >18 years of age;
  • Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin;
  • Anterior MI with ECG showing at least 1 mm of ST-segment elevation in 2 or more contiguous leads in V1-V4, or new (or presumably new) left bundle branch block;
  • Anticipated symptom onset to balloon or aspiration time of ≤5 hours;
  • The subject and his/her physician are willing to comply with specified follow-up evaluations;
  • The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB)
  • Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1/2 flow at the time of initial diagnostic angiography (prior to wire passage);
  • Based on coronary anatomy, PCI is indicated for revascularization;
  • Only one epicardial coronary artery will be treated;
  • Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).

Key Exclusion Criteria:

  • Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities);
  • An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
  • Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
  • Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
  • Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
  • Any contraindication to undergo MRI imaging.
  • Multivessel intervention required during the index procedure (subjects may be enrolled if treatment of more than one lesion in the LAD or its branches is required, however) (planned staged procedures are permitted with strong recommendation to be performed after 30-day clinical and MRI endpoints are completed);
  • Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export® Aspiration Catheter;
  • Features are present highly unfavorable for PCI;
  • Target lesion is present within a bypass graft conduit;
  • MI is due to thrombosis within or adjacent to a previously implanted stent;
  • Left ventriculography demonstrates severe mitral regurgitation or a VSD;
  • Unprotected left main stenosis >40% or that will require intervention
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976521


  Show 38 Study Locations
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
Principal Investigator: Greg W Stone, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00976521     History of Changes
Other Study ID Numbers: 901
First Posted: September 14, 2009    Key Record Dates
Results First Posted: July 8, 2013
Last Update Posted: July 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs