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

NCT00354406 | Completed Phase 4

• 1 other identifier: UP-DCT-200601
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myocardial Infarction

Keywords

Abciximab; Magnetic Resonance Imaging; Percutaneous Transluminal Coronary Angioplasty

Outcome Measures

Primary Outcomes (1)

• infarct size (% of left ventricular mass) as measured by delayed hyperenhancement magnetic resonance imaging at 6 months

  at 6 months after myocardial infarction

Secondary Outcomes (5)

• Angiographic TIMI Myocardial Perfusion grade and corrected TIMI frame count, assessed immediately after PCI.

  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.

  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.

  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

  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

  at 6 months after myocardial infarction

Study Arms (2)

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.

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.

Drug: abciximab

Interventions

abciximab DRUG

standard i.v. bolus of abciximab is administered at time of randomization in arm A, and at time of primary angioplasty in arm B.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Cardiothoracic Department, Ospedale Cisanello

Pisa, 56124, Italy

Location

Related Publications (1)

• 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.

  PMID: 11079658 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Anna S Petronio, MD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: April 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

IT (1)