The INFUSE - Anterior Myocardial Infarction (AMI) Study

Acute Anterior Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976521
• Other study ID #: 901
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: May 31, 2013
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Atrium Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: April 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Anterior Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Abciximab local infusion
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

Other:
• No local infusion
Intervention without local infusion

Procedure:
• Thrombus aspiration
Thrombus aspiration

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Braunau/Simbach	Braunau
Austria	Landeskrankenhaus Bruck/Mur	Bruck/Mur
Austria	Landeskrankenhaus Graz West	Graz
Austria	Univ. Klinik für Innere Medizin III Innsbruck	Innsbruck
Austria	Univ. Klinik für Innere Medizin II	Vienna
Germany	Charite- University Medicine Campus Benjamin Franklin	Berlin
Germany	Klinikum Villingen Kardiologie	Darmstadt
Germany	Facharzt fur Innere Medizin/Kardiologie	Ludwigshafen
Germany	Universitätsmedizin Mannheim - I. Medizinische Klinik	Mannheim
Germany	Klinikum der Universität Regensburg	Regensburg
Germany	Universtitätsklinikuim Ulm	Ulm
Netherlands	Ziekenhuis Rijnstate	Arnhem	NL
Netherlands	Catharina Hospital Eindhoven	Eindhoven
Netherlands	Isala Klinieken, Locatie de Weezenlanden	Zwolle
Poland	Polsko - Amerykanskie Kliniki Serca II Oddzial Kardiologiczny American Heart of Poland Sp. z o.o.	Bielsko-Biala
Poland	Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii	Krakow
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyn	Kraków
Poland	SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii	Kraków
Poland	Pracownia Hemodynamiki Oddzialu Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu	Opole
Poland	Centrum Kardiologii Inwazyjnej GVM Carint	Oswiecim
Poland	Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego,I Samodzielna Pracownia Hemodynamiki	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii	Warszawa
United Kingdom	Royal Victoria Hospital, Belfast Trust	Belfast
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	University Hospitals of Leicester - Glenfield Hospital	Leicester	U.k.
United Kingdom	King's College Hospital	London	U.k.
United Kingdom	Manchester Royal Infirmary	Manchester	U.k.
United Kingdom	Wythenshawe Hospital	Manchester	U.k.
United Kingdom	Freeman Hospital	Newcastle-upon-Tyne
United Kingdom	Southampton University Hospital	Southampton	U.k.
United States	Carolinas Medical Center-SHVI	Charlotte	North Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Moses Cone Vascular Center	Greensboro	North Carolina
United States	Harrisburg Hospital/ Pinnacle Health	Harrisburg	Pennsylvania
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Sentara Virginia Beach General Hospital	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Atrium Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion	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.	30 Days Post Index Procedure	No
Secondary	Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration	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.	30 Days	No