Trial Outcomes & Findings for Apixaban Pharmacokinetics in Bariatric Patients (APB) (NCT NCT02406885)
NCT ID: NCT02406885
Last Updated: 2020-12-22
Results Overview
To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
APB Study: Apixaban Pharmacokinetics in RYGB
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass (RYGB).
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in VSG
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy (VSG).
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apixaban Pharmacokinetics in Bariatric Patients (APB)
Baseline characteristics by cohort
| Measure |
APB Study: Apixaban Pharmacokinetics in VSG
n=16 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in RYGB
n=17 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
42 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsTo determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline.
Outcome measures
| Measure |
APB Study: Apixaban Pharmacokinetics in VSG
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in RYGB
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
Change in Pharmacokinetics as Assessed by Cmax (Max Concentration)
|
5.3 ng/ml
Standard Deviation 19.98
|
-6.7 ng/ml
Standard Deviation 25.35
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsTo determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in AUC (ng\*h/ml) between 12 months and baseline.
Outcome measures
| Measure |
APB Study: Apixaban Pharmacokinetics in VSG
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in RYGB
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC)
|
-168.25 ng*h/ml
Standard Deviation 226.36
|
-166.34 ng*h/ml
Standard Deviation 264.36
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: This outcome measure was not assessed. Data was not collected.
To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 monthsTo determine the durability or change in pharmacodynamics of apixaban in patients with obesity following one of two bariatric surgical procedures. Reported data is the difference between 12 months and baseline. Factor Xa levels is measured in "percent activity".
Outcome measures
| Measure |
APB Study: Apixaban Pharmacokinetics in VSG
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in RYGB
n=14 Participants
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity)
|
-7.3 Percent Activity
Standard Deviation 17.8
|
-15.7 Percent Activity
Standard Deviation 21.03
|
Adverse Events
APB Study: Apixaban Pharmacokinetics in RYGB
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
APB Study: Apixaban Pharmacokinetics in VSG
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
APB Study: Apixaban Pharmacokinetics in RYGB
n=17 participants at risk
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in VSG
n=16 participants at risk
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
5.9%
1/17 • Number of events 1 • 12 months
|
0.00%
0/16 • 12 months
|
|
Cardiac disorders
Sudden Cardiac Death
|
0.00%
0/17 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/17 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
APB Study: Apixaban Pharmacokinetics in RYGB
n=17 participants at risk
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
APB Study: Apixaban Pharmacokinetics in VSG
n=16 participants at risk
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater pre vs. post surgery for patients undergoing vertical sleeve gastrectomy.
Apixaban: New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
|
|---|---|---|
|
General disorders
migraine headache
|
0.00%
0/17 • 12 months
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Zoster Rash
|
5.9%
1/17 • Number of events 1 • 12 months
|
0.00%
0/16 • 12 months
|
Additional Information
Dr. Brent Petty
The Johns Hopkins University School of Medicine
Phone: 410-955-8181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place