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.

Condition	Treatment or Intervention	Phase
Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency	Drug: TP10	Phase II

Further Study Details: 

Primary Outcomes: Reduction in death & myocardial infarction (MI)
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

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
• Conditons that may interfere with interpretation of electrocardiogram data
• History of immune deficiency syndrome
• Planned supplemental cardiac surgery or other surgery
• Pregnancy or lactation

Carrie Delaney      781-433-3164    cdelaney@avantimmune.com
Maribel Rueda      781-433-3115    mrueda@avantimmune.com

California
      San Francisco,  California,  94115,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Sarasota,  Florida,  34239,  United States; Recruiting
      Orlando,  Florida,  32803,  United States; Recruiting
      Gainesville,  Florida,  32610,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  30342,  United States; Recruiting
Illinois
      Chicago,  Illinois,  60612,  United States; Recruiting
Maryland
      Towson,  Maryland,  21204,  United States; Recruiting
Massachusetts
      Boston,  Massachusetts,  02118,  United States; Recruiting
      Springfield,  Massachusetts,  01199,  United States; Recruiting
Michigan
      Lansing,  Michigan,  48910,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  45219,  United States; Recruiting
Tennessee
      Memphis,  Tennessee,  38120,  United States; Recruiting
Texas
      Houston,  Texas,  77030,  United States; Recruiting
Virginia
      Falls Church,  Virginia,  22042,  United States; Recruiting
      Danville,  Virginia,  24541,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  53792,  United States; Recruiting
      Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  TP10-ACS-002
Record last reviewed:  January 2005
Last Updated:  February 1, 2005
Record first received:  April 29, 2004
ClinicalTrials.gov Identifier:  NCT00082121
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08