Status:
COMPLETED
Pilot Study of Hemoglobin Based Oxygen Therapeutics in Elective Coronary Revascularization
Lead Sponsor:
Biopure Corporation
Conditions:
Angina Pectoris
Unstable Angina
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 disc...
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, vas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00317512
Start Date
December 1 2003
End Date
July 1 2007
Last Update
May 16 2008
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Site # 5 Onze Lieve Vrouw Ziekenhuis (OLVZ)
Aalst, Belgium
2
Site # 6 Antwerpen
Antwerp, Belgium
3
Site # 2 Herzzentrum
Leipzig, Germany
4
Site # 3 OLVG Amsterdam
Amsterdam, Netherlands