Trial Outcomes & Findings for A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis (NCT NCT00789399)
NCT ID: NCT00789399
Last Updated: 2022-09-08
Results Overview
there were 2 events; one in placebo group and one in fondaparinux group
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
11 days
Results posted on
2022-09-08
Participant Flow
Participant milestones
| Measure |
Fondaparinux
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Fondaparinux: Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
|
Placebo
Placebo: subcutaneous equivolume isotonic saline
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
37
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis
Baseline characteristics by cohort
| Measure |
Fondaparinux
n=41 Participants
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Fondaparinux: Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
|
Placebo
n=37 Participants
Placebo: subcutaneous equivolume isotonic saline
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
37 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 daysthere were 2 events; one in placebo group and one in fondaparinux group
Outcome measures
| Measure |
Fondaparinux
n=41 Participants
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Fondaparinux: Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
|
Placebo
n=37 Participants
Placebo: subcutaneous equivolume isotonic saline
|
|---|---|---|
|
Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 35 daysOutcome measures
| Measure |
Fondaparinux
n=41 Participants
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Fondaparinux: Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
|
Placebo
n=37 Participants
Placebo: subcutaneous equivolume isotonic saline
|
|---|---|---|
|
Number of Participants With a Venous Thromboembolisms to 35 Days
|
1 Participants
|
1 Participants
|
Adverse Events
Fondaparinux Subjects
Serious events: 34 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo Subjects
Serious events: 18 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fondaparinux Subjects
n=41 participants at risk
pts received fondaparinux
|
Placebo Subjects
n=37 participants at risk
patients received placebo
|
|---|---|---|
|
Vascular disorders
DVT
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Cardiac disorders
Myocardial Infarction
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Cardiac disorders
CHF
|
24.4%
10/41 • Number of events 10 • 2 year follow up
|
10.8%
4/37 • Number of events 4 • 2 year follow up
|
|
Cardiac disorders
cardiac tamponade
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Cardiac disorders
cardiac arrhythmia
|
17.1%
7/41 • Number of events 7 • 2 year follow up
|
5.4%
2/37 • Number of events 2 • 2 year follow up
|
|
Cardiac disorders
Afib/Aflutter
|
26.8%
11/41 • Number of events 11 • 2 year follow up
|
10.8%
4/37 • Number of events 4 • 2 year follow up
|
|
Cardiac disorders
Other Cardiac
|
17.1%
7/41 • Number of events 8 • 2 year follow up
|
8.1%
3/37 • Number of events 3 • 2 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Resp Arrest
|
4.9%
2/41 • Number of events 2 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
5.4%
2/37 • Number of events 2 • 2 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
14.6%
6/41 • Number of events 6 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
12.2%
5/41 • Number of events 5 • 2 year follow up
|
5.4%
2/37 • Number of events 2 • 2 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Other Pulmonary
|
7.3%
3/41 • Number of events 3 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Infections and infestations
Surgical Site Infection
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Infections and infestations
Other Infections
|
9.8%
4/41 • Number of events 4 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Nervous system disorders
Other Neurological
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Renal and urinary disorders
Renal Insufficiency
|
4.9%
2/41 • Number of events 2 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Gastrointestinal disorders
Nausea/vomiting
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Gastrointestinal disorders
Other GI
|
12.2%
5/41 • Number of events 5 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Blood and lymphatic system disorders
Anemia
|
17.1%
7/41 • Number of events 7 • 2 year follow up
|
8.1%
3/37 • Number of events 3 • 2 year follow up
|
|
General disorders
other
|
31.7%
13/41 • Number of events 16 • 2 year follow up
|
21.6%
8/37 • Number of events 9 • 2 year follow up
|
Other adverse events
| Measure |
Fondaparinux Subjects
n=41 participants at risk
pts received fondaparinux
|
Placebo Subjects
n=37 participants at risk
patients received placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Other, Pulmonary
|
34.1%
14/41 • Number of events 25 • 2 year follow up
|
37.8%
14/37 • Number of events 26 • 2 year follow up
|
|
Cardiac disorders
Other, Cardiac
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
10.8%
4/37 • Number of events 4 • 2 year follow up
|
|
Musculoskeletal and connective tissue disorders
Other
|
4.9%
2/41 • Number of events 2 • 2 year follow up
|
5.4%
2/37 • Number of events 2 • 2 year follow up
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
Infections and infestations
surgical site infection
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
0.00%
0/37 • 2 year follow up
|
|
Gastrointestinal disorders
Nausea/vomiting
|
2.4%
1/41 • Number of events 1 • 2 year follow up
|
2.7%
1/37 • Number of events 1 • 2 year follow up
|
|
General disorders
other
|
12.2%
5/41 • Number of events 7 • 2 year follow up
|
18.9%
7/37 • Number of events 11 • 2 year follow up
|
Additional Information
Chief Operating Officer
Prairie Education and Research Cooperative
Phone: 217 492 9104
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place