Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization

Biopure

Status and phase

Completed

Phase 2

Conditions

Acute Coronary Syndrome

Coronary Occlusion

Treatments

Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00479895

COR-0002

Details and patient eligibility

About

The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier, HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for surgical patients, has the ability to restore tissue oxygenation in persistently ischemic tissue. The development of this new class of compounds, referred to as oxygen therapeutics, provides an opportunity to test the safety and efficacy of a new approach to management of myocardial ischemia.

Full description

Because of their ability to perfuse and deliver oxygen, hemoglobin-based oxygen carriers (HBOC) may be considered in the treatment of several ischemic conditions, such as acute coronary syndromes (ACS). Elective percutaneous intervention (PCI) induces transient myocardial ischemia due to reduction of coronary flow during balloon inflation in the coronary artery, thus simulating in a control setting, the occurrence of an ACS.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent before initiation of any study-related procedure and agreement to comply with all protocol-specific procedures
Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braundwald class 1-3, B) or documented silent ischemia
Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances.
Normal left ventricular wall motion on left ventricular angiogram or on echocardiogram with preserved systolic global LV function
Non-occlusive stenosis, located in the proximal segments of the left anterior descending artery (LAD) (segments 6 and/or 7) and/or circumflex artery (CFX) (segments 11 and/or 12) or right coronary artery (RCA) (segments 1, 2 and/or 3) for which there is clinical indication to percutaneous treatment with coronary stenting
Successful PCI with stenting on the target vessel
Older than 18 years and younger than 80 years of age

Exclusion criteria

Active ischemia at the initiation of the study procedure
Non-ST segment elevation myocardial infarction
History or ECG evidence of prior MI in the territory supplied by the vessel undergoing PCI, IV conduction defects/baseline ST-segment abnormalities on the surface ECG
Moderate to severe aortic or mitral valve disease
Evidence of LV hypertrophy on the echocardiogram IVS > 13 and/or PW > 13mm
Angiographically visible collateral vessels to the target vessel
Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (> 140/100mmHg)
Uncompensated congestive heart failure or signs of pulmonary edema
Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support
Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
Confirmed pregnancy
Systemic mastocytosis
Hypoxemia (need for mechanical ventilation
Known history of COPD with FEV 1s < 1.0 liter
Renal impairment: creatinine > 1.6 mg/dl
Participation in another trial with an investigational drug or device including follow-up period, within the last 30 days before enrollment

Additional exclusion criteria at the end of PCI (before randomization)

Coronary TIMI flow in the treated artery is less than 3
Serious arrhythmias during/following the PCI was noted
Coronary spasm following PCI
Any deterioration in the subject's "risk" status between informed consent and randomization