Treatment of several ischemic conditions, such as acute coronary syndromes (ACS)
Conditions
Interventions
Product Name: Hemopure
Product Code: HBOC-201
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: haemoglobin glutamer-250 (bovine)
Other descriptive name: polymerised bovine haemoglobin
C
Sponsors
Biopure Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients to be included in the study must meet the following inclusion criteria: 1. Written informed consent provided before initiation of any study-related procedure, and before any pre-procedural sedation, and agreement to comply with all protocol-specific procedures. 2. Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braunwald class 1-3, B) or documented silent ischemia. 3. Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances. 4. Normal left ventricular (LV) wall motion on left ventricular angiogram or on echocardiogram with preserved (ejection fraction: 55%) systolic global LV function. 5. 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 percutanous treatment with coronary stenting. 6. Successful PCI with stenting on the target vessel. 7. Older than 18 years and younger than 80 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following exclusion criteria apply, prior to study enrollment: 1. Active ischemia at the initiation of the study procedure (i.e. post-PCI). 2. Non-ST segment elevation myocardial infarction (patients with any troponin elevation within the last 5 days). 3. 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. 4. Evidence of left ventricular (LV) hypertrophy on the echocardiogram. 5. Angiographically visible collateral vessels to the target vessel. 6. Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (> 140/100 mmHG). 7. Uncompensated congestive heart failure or signs of pulmonary edema. 8. Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support. 9. Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye. 10. Confirmed pregnancy. 11. Systemic mastocytosis. 12. Hypoxemia (need for mechanical ventilation). 13. Known history of COPD with FEV 1s 1. 6 g/dl. 15. 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. Additional exclusion criteria at the end of PCI (i.e. before randomization) Patients will be excluded from further study participation and replaced if one or more of the following conditions occurs: 1. Coronary TIMI flow in the treated artery is less than 3. 2. Serious arrhythmia during/following the PCI was noted (ventricular fibrillation or ventricular tachycardia). 3. Coronary spasm following PCI. 4. Any changes in the patient’s “risk” status between informed consent and randomization, in particular with regard to systemic hemodynamic alterations (a systolic blood pressure >180 mmHG, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) >20 mmHG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : To investigate whether intracoronary delivery (IC) of HBOC-201® to the myocardium at risk during coronary flow interruption mitigates ischemia as measured by LV pressure-volume loop analysis and continuous Holter ECG recording. ;Secondary Objective: Secondary objectives : 1. to study clinical signs and symptoms of myocardial ischemia during the investigational procedure; 2. to collect safety information regarding the IC delivery of HBOC-201®; 3. to collect (additional) information concerning the occurrence and (potential) management of systemic vasoconstrictive effects (increase in systemic blood pressure) during study drug infusion; 4. to investigate the local vasoconstrictive effect on coronary artery diameters as assessed with off-line quantitative coronary analysis (QCA) based on angiograms performed before and immediately after the placebo and HBOC-201® infusions. ;Primary end point(s): To study the change in left ventricular relaxation indices (relaxation time constant [Tau, ms] and pressure-half time [PHT, ms] as measured by LV pressure-volume loop analysis) and the change in the sum of ST segment deviations (as assessed by continuous 12-lead Holter ECG monitoring) compared to baseline. | — |
Countries
Belgium
Outcome results
None listed