The INFUSE - Anterior Myocardial Infarction (AMI) Study

NCT ID: NCT00976521

Last Updated: 2013-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-04-30

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.

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.

Conditions

Acute Anterior Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local infusion, thrombus aspiration

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.

Group Type: EXPERIMENTAL

Abciximab local infusion

Intervention Type: DRUG

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

Thrombus aspiration

Intervention Type: PROCEDURE

Thrombus aspiration

Local infusion, no aspiration

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration

Group Type: EXPERIMENTAL

Abciximab local infusion

Intervention Type: DRUG

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

No local infusion, thrombus aspiration

No local infusion of abciximab, thrombus aspiration.

Group Type: ACTIVE_COMPARATOR

No local infusion

Intervention Type: OTHER

Intervention without local infusion

Thrombus aspiration

Intervention Type: PROCEDURE

Thrombus aspiration

No local infusion, no aspiration

No local infusion abciximab and no thrombus aspiration

Group Type: ACTIVE_COMPARATOR

No local infusion

Intervention Type: OTHER

Intervention without local infusion

Interventions

Abciximab local infusion

Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

Intervention Type: DRUG

No local infusion

Intervention without local infusion

Intervention Type: OTHER

Thrombus aspiration

Thrombus aspiration

Intervention Type: PROCEDURE

Eligibility Criteria

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg W Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Washington Adventist Hospital

Takoma Park, Maryland, United States

Carolinas Medical Center-SHVI

Charlotte, North Carolina, United States

Moses Cone Vascular Center

Greensboro, North Carolina, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Harrisburg Hospital/ Pinnacle Health

Harrisburg, Pennsylvania, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, United States

Landeskrankenhaus Bruck/Mur

Bruck/Mur, Austria, Austria

Landeskrankenhaus Graz West

Graz, Austria, Austria

Univ. Klinik für Innere Medizin III Innsbruck

Innsbruck, Austria, Austria

Univ. Klinik für Innere Medizin II

Vienna, Austria, Austria

Landeskrankenhaus Braunau/Simbach

Braunau am Inn, , Austria

Universitätsmedizin Mannheim - I. Medizinische Klinik

Mannheim, Germany, Germany

Klinikum der Universität Regensburg

Regensburg, Germany, Germany

Charite- University Medicine Campus Benjamin Franklin

Berlin, , Germany

Klinikum Villingen Kardiologie

Darmstadt, , Germany

Facharzt fur Innere Medizin/Kardiologie

Ludwigshafen, , Germany

Universtitätsklinikuim Ulm

Ulm, , Germany

Ziekenhuis Rijnstate

Arnhem, NL, Netherlands

Catharina Hospital Eindhoven

Eindhoven, , Netherlands

Isala Klinieken, Locatie de Weezenlanden

Zwolle, , Netherlands

Polsko - Amerykańskie Kliniki Serca II Oddział Kardiologiczny American Heart of Poland Sp. z o.o.

Bielsko-Biala, Poland, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyń

Krakow, Poland, Poland

SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii

Krakow, Poland, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii

Warsaw, Poland, Poland

Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego,I Samodzielna Pracownia Hemodynamiki

Warsaw, Poland, Poland

Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

Krakow, , Poland

Pracownia Hemodynamiki Oddziału Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu

Opole, , Poland

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, , Poland

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

Southampton University Hospital

Southampton, U.k., United Kingdom

Royal Victoria Hospital, Belfast Trust

Belfast, , United Kingdom

Bristol Heart Institute

Bristol, , United Kingdom

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Countries

United States; Austria; Germany; Netherlands; Poland; United Kingdom

References

Giustino G, Redfors B, Brener SJ, Kirtane AJ, Genereux P, Maehara A, Dudek D, Neunteufl T, Metzger DC, Crowley A, Mehran R, Gibson CM, Stone GW. Correlates and prognostic impact of new-onset heart failure after ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: insights from the INFUSE-AMI trial. Eur Heart J Acute Cardiovasc Care. 2018 Jun;7(4):339-347. doi: 10.1177/2048872617719649. Epub 2017 Aug 22.

Reference Type: DERIVED

PMID: 28828881 (View on PubMed)

Tomey MI, Mehran R, Brener SJ, Maehara A, Witzenbichler B, Dizon JM, El-Omar M, Xu K, Gibson CM, Stone GW. Sex, adverse cardiac events, and infarct size in anterior myocardial infarction: an analysis of intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction (INFUSE-AMI). Am Heart J. 2015 Jan;169(1):86-93. doi: 10.1016/j.ahj.2014.06.019. Epub 2014 Jul 3.

Reference Type: DERIVED

PMID: 25497252 (View on PubMed)

Guerchicoff A, Brener SJ, Maehara A, Witzenbichler B, Fahy M, Xu K, Gersh BJ, Mehran R, Gibson CM, Stone GW. Impact of delay to reperfusion on reperfusion success, infarct size, and clinical outcomes in patients with ST-segment elevation myocardial infarction: the INFUSE-AMI Trial (INFUSE-Anterior Myocardial Infarction). JACC Cardiovasc Interv. 2014 Jul;7(7):733-40. doi: 10.1016/j.jcin.2014.01.166.

Reference Type: DERIVED

PMID: 25060015 (View on PubMed)

Stone GW, Witzenbichler B, Godlewski J, Dambrink JH, Ochala A, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Dizon JM, Wolff SD, Brener SJ, Mehran R, Maehara A, Gibson CM. Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):527-34. doi: 10.1161/CIRCINTERVENTIONS.113.000644. Epub 2013 Oct 1.

Reference Type: DERIVED

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Brener SJ, Maehara A, Dizon JM, Fahy M, Witzenbichler B, Parise H, El-Omar M, Dambrink JH, Mehran R, Oldroyd K, Gibson CM, Stone GW. Relationship between myocardial reperfusion, infarct size, and mortality: the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. JACC Cardiovasc Interv. 2013 Jul;6(7):718-24. doi: 10.1016/j.jcin.2013.03.013.

Reference Type: DERIVED

PMID: 23866184 (View on PubMed)

Brener SJ, Witzenbichler B, Maehara A, Dizon J, Fahy M, El-Omar M, Dambrink JH, Genereux P, Mehran R, Oldroyd K, Parise H, Gibson CM, Stone GW. Infarct size and mortality in patients with proximal versus mid left anterior descending artery occlusion: the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction (INFUSE-AMI) trial. Am Heart J. 2013 Jul;166(1):64-70. doi: 10.1016/j.ahj.2013.03.029. Epub 2013 Apr 30.

Reference Type: DERIVED

PMID: 23816023 (View on PubMed)

Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.

Reference Type: DERIVED

PMID: 22447888 (View on PubMed)

Gibson CM, Maehara A, Lansky AJ, Wohrle J, Stuckey T, Dave R, Cox D, Grines C, Dudek D, Steg G, Parise H, Wolff SD, Cristea E, Stone GW. Rationale and design of the INFUSE-AMI study: A 2 x 2 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. Am Heart J. 2011 Mar;161(3):478-486.e7. doi: 10.1016/j.ahj.2010.10.006. Epub 2011 Jan 28.

Reference Type: DERIVED

PMID: 21392601 (View on PubMed)

Other Identifiers

901

Identifier Type: -

Identifier Source: org_study_id