Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization

May 15, 2008 updated by: Biopure Corporation

A Multi-Center,Randomized,Double-Blind,Placebo-Controlled,Dose Finding Pilot Study, to Evaluate Safety/Feasibility of HBOC-201 in Elective Percutaneous Coronary Revascularization of Subjects With Acute Coronary Syndromes

The purpose of this study is to assess the safety and feasibility of a novel oxygen carrying solution, HBOC-201, in the setting of PCI for Acute Coronary Syndromes from randomization til hospital discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute coronary syndromes are due to an acute or subacute primary reduction of myocardial oxygen supply provoked by disruption of an atherosclerotic plaque associated with inflammation, thrombosis, vasoconstriction and microembolization. Occlusive thrombosis superimposed on a ruptured atheroma in an epicardial coronary artery is firmly established as the immediate cause of an acute ST-segment Elevation Myocardial Infarction (STEMI). Rapid restoration of blood flow (oxygen supply) to jeopardized myocardium limits necrosis and reduces mortality. This can be accomplished medically with a thrombolytic agent, or mechanically, with so-called primary balloon angioplasty or stenting. Primary percutaneous coronary intervention (PCI) has become the preferred therapy for STEMI in most developed countries.

HBOC-201 is a solution belonging to a new class of biologic oxygen therapeutics, hemoglobin based oxygen carriers. HBOC-201 is a crosslinked and glutaraldehyde-polymerized hemoglobin (Hb) extracted from isolated bovine red blood cells. On a gram-for-gram basis, HBOC-201 was calculated to be approximately three times more potent than stored fresh red blood cell hemoglobin at restoring baseline tissue oxygenation following severe acute anemia. Evaluation of this Hemoglobin Based Oxygen Carrier has been undertaken in 57 preclinical studies and 21 human clinical trials. The compound is under review by the US FDA and has been approved in the Republic of South Africa. However, HBOC-201 has not yet been evaluated in the setting of this disease (narrowing of a coronary artery).

Biopure will be studying the safety and feasibility of HBOC-201 in patients with typical symptoms of Unstable Angina or Non ST-segment Elevation Myocardial Infarction eligible to undergo invasive revascularization through a PCI procedure.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
      • Antwerpen, Belgium
        • Site # 6 Antwerpen
  • Germany
      • Leipzig, Germany
        • Site # 2 Herzzentrum
  • Netherlands
      • Amsterdam, Netherlands
        • Site # 3 OLVG Amsterdam
      • Amsterdam, Netherlands
        • Site # 4 Academisch Medisch Centrum (AMC)
      • Rotterdam, Netherlands
        • Site # 1 Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent provided before initiation of any study-related procedure, and before any pre-procedural sedation, and agreement to comply with all protocol-specified procedures
  • Acute Coronary Syndrome (Stable and unstable angina or non ST segment Elevation Myocardial Infarction (UA/non-STEMI) [Braunwald class I-III Class B], Appendix 1).
  • Single vessel disease of the Left Coronary Artery (LCA)
  • One vessel disease of the Right Coronary Artery (RCA)
  • Have a single de novo lesion
  • Older than 18 years and younger than 75 years of age
  • Eligible to undergo PCI on the target vessel

Exclusion Criteria:

  • Previous Q-wave myocardial infarction
  • Congestive heart failure with Left ventricular Ejection Fraction <35%
  • Confirmed pregnancy
  • Anemia to a hemoglobin level <8.5g/dl
  • Systemic mastocytosis
  • History of known haemorrhagic stroke at any time or any stroke less than or equal to 30 days prior to randomization
  • Severe hypertension (>180/110mmHG) not adequately controlled by antihypertensive therapy at time of study entry
  • Need for mechanical ventilation
  • Renal impairment: Creatinine > 1.6mg/dl
  • Known history of COPD with FEV 1s < 1.0 liter
  • Contra-indications to the use of adenosine, i.e.History of bronchospasm and/or ongoing therapy with theophylline derivatives, >1 degree atrioventricular block in the absence of a functioning electronic pacemaker and treatment with dipyridamole within the prior 24 hours
  • Patients with significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support or pulmonary edema
  • History of or clinical documentation of severe aortic/mitral valve stenosis, significant aortic valve insufficiency
  • Participation in another trial with an investigational drug or device (of other investigations) including the follow-up period, within the last 30 days before enrollment
  • Inability or unwillingness to perform 30 day follow up
  • Concomitant disease that interferes with prognosis (life expectancy of less than or equal to 6 months
  • Contra-indications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
  • Patient weight > 110kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
Procedure: Percutaneous Coronary Revascularization
Drug: Voluven
Active Comparator: 2
HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes
Procedure: Percutaneous Coronary Revascularization
Drug: Voluven
Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)
Experimental: 3
HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by HBOC-201 at 7.7 ml/min over 15 minutes
Procedure: Percutaneous Coronary Revascularization
Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Other adverse events
Renal dysfunction
In hospital thrombotic events
Anaphylactic reactions
Inflammatory reactions
Substantial changes to systemic & coronary hemodynamics
Circulatory overload
Untoward drug interaction effects
substantial changes in laboratory parameters
Life threatening cardiac arrhythmias
Feasibility:
Number of subjects requiring premature discontinuation of study drug for clinical or logistical reasons

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopure Corporation

Investigators

  • Principal Investigator: P W Serruys, Professor, University Medical Center Rotterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 21, 2006

First Submitted That Met QC Criteria

April 21, 2006

First Posted (Estimate)

April 25, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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