Efficacy Study on Early Versus Late Abciximab Administration During Primary Coronary Angioplasty

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Prof. Anna Sonia Petronio, University of Pisa
ClinicalTrials.gov Identifier:
NCT00354406
First received: July 19, 2006
Last updated: November 13, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: abciximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the Efficacy on Myocardial Infarct Size Reduction of Early vs. Late Abciximab Administration During Primary Percutaneous Coronary Angioplasty

Resource links provided by NLM:


Further study details as provided by University of Pisa:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angiographic TIMI Myocardial Perfusion grade and corrected TIMI frame count, assessed immediately after PCI. [ Time Frame: final angiography at the end of PCI ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Drug: abciximab
standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.
Active Comparator: B
Patients in Arm B (Late abciximab arm) will receive abciximab at time of primary angioplasty, directly in the Cath Lab.
Drug: abciximab
standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.

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:

  1. Improves angiographic TMP grade and cTFC compared with primary PCI group, immediately after PCI.
  2. Reduces the extension of no-reflow areas, as assessed by DE-MRI before discharge.
  3. Reduces the extension of microvasculature damage as assessed by fist-pass perfusion study by MRI before discharge.
  4. Improves regional wall motion and left ventricular ejection fraction (LVEF) as measured by cine MR and 2D echocardiography at 6 months
  5. Reduces the occurrence of LV remodeling at 6 month follow up.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354406

Locations
Italy
Cardiothoracic Department, Ospedale Cisanello
Pisa, Italy, 56124
Sponsors and Collaborators
University of Pisa
Eli Lilly and Company
Investigators
Principal Investigator: Anna S Petronio, MD University of Pisa
  More Information

Publications:
Responsible Party: Prof. Anna Sonia Petronio, Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana, University of Pisa
ClinicalTrials.gov Identifier: NCT00354406     History of Changes
Other Study ID Numbers: UP-DCT-200601
Study First Received: July 19, 2006
Last Updated: November 13, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by University of Pisa:
Abciximab
Magnetic Resonance Imaging
Percutaneous Transluminal Coronary Angioplasty

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on July 13, 2014