Angina PectorisPhase 2NCT00317512
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
A Phase 2 study testing Percutaneous Coronary Revascularization, Hemoglobin-Based Oxygen Carrier-201 (HBOC-201) and Voluven in people with Angina Pectoris and Unstable Angina, run by Biopure Corporation at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris, Unstable Angina, Myocardial Infarction
- What is being tested?
- Percutaneous Coronary Revascularization, Hemoglobin-Based Oxygen Carrier-201 (HBOC-201) and Voluven
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Dec 2003to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Netherlands3 sites
Site # 3 OLVG Amsterdam
Amsterdam
Site # 4 Academisch Medisch Centrum (AMC)
Amsterdam
Site # 1 Erasmus Medical Center
Rotterdam
Belgium2 sites
Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
Aalst
Site # 6 Antwerpen
Antwerp
About this study
Official title: 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.
Read the 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.
- Conditions
- Angina Pectoris, Unstable Angina, Myocardial Infarction
- Being tested
- Percutaneous Coronary Revascularization, Hemoglobin-Based Oxygen Carrier-201 (HBOC-201), Voluven
- Keywords
- Hemoglobin Based Oxygen carrier, HBOC 201, Percutaneous Revascularization, Percutaneous Coronary Intervention, Non ST-segment Elevation Myocardial Infarction, Tissue Oxygenation, Transluminal Percutaneous Coronary Angioplasty
- Medical subject headings
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary RevascularizationProcedure or surgery
Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)Drug
VoluvenDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Voluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes Receives: Procedure: Percutaneous Coronary Revascularization; Drug: Voluven |
| 2 | Active comparator | HBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes Receives: Procedure: Percutaneous Coronary Revascularization; Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201); Drug: Voluven |
| 3 | Experimental | 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 Receives: Procedure: Percutaneous Coronary Revascularization; Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
In hospital thrombotic events
Anaphylactic reactions
Inflammatory reactions
Substantial changes to systemic & coronary hemodynamics
Circulatory overload
Renal dysfunction
Untoward drug interaction effects
substantial changes in laboratory parameters
Life threatening cardiac arrhythmias
Other adverse events
Feasibility:
Number of subjects requiring premature discontinuation of study drug for clinical or logistical reasons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startDec 2003
- Primary completionApr 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biopure Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P W Serruys, Professor, Principal investigator, University Medical Center Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317512
- Sponsor's protocol ID
- COR-0001
- Status last verified
- May 2008
- First submitted
- 21 Apr 2006
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel EA, Dube GP, Symons J. Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for CAD. EuroIntervention. 2008 Mar;3(5):600-9. doi: 10.4244/eijv3i5a108.
PubMed 19608488
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00317512
- Acronym / sponsor ID
- COR-0001
- Conditions
- Angina Pectoris, Unstable Angina, Myocardial Infarction
- Keywords
- Hemoglobin Based Oxygen carrier, HBOC 201, Percutaneous Revascularization, Percutaneous Coronary Intervention, Non ST-segment Elevation Myocardial Infarction, Tissue Oxygenation, Transluminal Percutaneous Coronary Angioplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Biopure CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 25 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Percutaneous Coronary Revascularization, Drug: VoluvenVoluven will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes |
| 2 | Active comparator | Procedure: Percutaneous Coronary Revascularization, Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201), Drug: VoluvenHBOC-201 will be administered at 7.7 ml/min over 15 minutes,followed by Voluven at 7.7 ml/min over 15 minutes |
| 3 | Experimental | Procedure: Percutaneous Coronary Revascularization, Drug: Hemoglobin-Based Oxygen Carrier-201 (HBOC-201)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Revascularization | Procedure or surgery | 1, 2, 3 |
| Hemoglobin-Based Oxygen Carrier-201 (HBOC-201) | Drug | 2, 3 |
| Voluven | Drug | 1, 2 |
Primary outcome
Safety
In hospital thrombotic events
Anaphylactic reactions
Inflammatory reactions
Substantial changes to systemic & coronary hemodynamics
Circulatory overload
Renal dysfunction
Untoward drug interaction effects
substantial changes in laboratory parameters
Life threatening cardiac arrhythmias
Other adverse events
Feasibility:
Number of subjects requiring premature discontinuation of study drug for clinical or logistical reasons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
- Results publication: PubMed 19608488Serruys PW, Vranckx P, Slagboom T, Regar E, Meliga E, de Winter RJ, Heyndrickx G, Schuler G, van Remortel EA, Dube GP, Symons J. Haemodynamic effects, safety, and tolerability of haemoglobin-based oxygen carrier-201 in patients undergoing PCI for CAD. EuroIntervention. 2008 Mar;3(5):600-9. doi: 10.4244/eijv3i5a108.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P W Serruys, Professor principal investigator
University Medical Center Rotterdam
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Percutaneous Coronary Revascularization, Hemoglobin-Based Oxygen Carrier-201 (HBOC-201) and Voluven in people with Angina Pectoris and Unstable Angina, run by Biopure Corporation at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.