Aortic Valve Insufficiency, Coronary Arteriosclerosis, Mitral Valve Insufficiency, Myocardial Ischemia
Conditions
Keywords
cardiac bypass, CABG, complement activation
Brief summary
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.
Detailed description
During cardiac surgery, a substance called complement is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.
Interventions
DRUGTP10
Sponsors
Avant Immunotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB) * CABG alone or with valve surgery
Exclusion criteria
* Acute myocardial infarction (heart attack) within a 3 days of entering the study * Conditions that may interfere with interpretation of electrocardiogram data * History of immune deficiency syndrome * Planned supplemental cardiac surgery or other surgery * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in death & myocardial infarction (MI) | — |
Countries
United States
Outcome results
None listed