Myocardial Infarction Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
| Completed |
NCT04507529 -
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
|
N/A | |
| Recruiting |
NCT06066970 -
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
|
||
| Recruiting |
NCT03620266 -
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
|
N/A | |
| Completed |
NCT04097912 -
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
|
||
| Completed |
NCT04153006 -
Comparison of Fingerstick Versus Venous Sample for Troponin I.
|
||
| Completed |
NCT03668587 -
Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
|
||
| Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
| Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
| Recruiting |
NCT05371470 -
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
|
N/A | |
| Recruiting |
NCT04562272 -
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
|
N/A | |
| Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
| Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
| Not yet recruiting |
NCT06007950 -
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
|
N/A | |
| Withdrawn |
NCT05327855 -
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
|
Phase 2 | |
| Recruiting |
NCT02876952 -
High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients
|
N/A | |
| Completed |
NCT02711631 -
Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
|
N/A | |
| Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
| Completed |
NCT02552407 -
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
|
N/A | |
| Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A |