Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apixaban in Patients With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179177
Recruitment Status : Terminated (funding has been exhausted)
First Posted : July 1, 2014
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nirmish Shah, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Vaso-occlusive Crisis
Reduction in Hospitalizations
Sickle Cell Disease
Interventions Drug: Apixaban
Drug: Placebo
Enrollment 16
Recruitment Details Patients with sickle cell disease were enrolled as an outpatient in clinic while at baseline pain from January 2015 to September 2017.
Pre-assignment Details  
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Period Title: Overall Study
Started 8 8
Completed 6 6
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             1
Arm/Group Title Apixaban Placebo Total
Hide Arm/Group Description

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
30  (6.2) 33  (3.9) 31.5  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
5
  62.5%
5
  62.5%
10
  62.5%
Male
3
  37.5%
3
  37.5%
6
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
 100.0%
8
 100.0%
16
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
 100.0%
8
 100.0%
16
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8
 100.0%
8
 100.0%
16
 100.0%
1.Primary Outcome
Title Change in Pain as Measured by Visual Analog Scale (VAS)
Hide Description The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other.
Time Frame Month 1 to Month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants in each group (Apixaban and Placebo) did not return for Month 8 visit.
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description:

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1  (0.5) 0  (0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apixaban, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Thrombin Generation Using D-dimer Measurement as a Surrogate
Hide Description [Not Specified]
Time Frame Enrollment to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description:

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Daily Pain Scores While Hospitalized as Measured by VAS
Hide Description The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other. Secondary analysis will be performed to evaluate differences when patients are hospitalized and on study drug versus placebo.
Time Frame up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants from each group (Apixaban and Placebo) did not return for Month 8 visit.
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description:

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.4  (3.4) 6.6  (3.8)
4.Secondary Outcome
Title Number of Hospitalizations During Treatment
Hide Description [Not Specified]
Time Frame up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants from each group (Apixaban and Placebo) did not return for 8 Month visit.
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description:

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: hospitalizations
3  (3.3) 1.5  (1.5)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apixaban Placebo
Hide Arm/Group Description

Active drug Apixaban 2.5mg taken by mouth twice a day

Apixaban: Drug is taken by mouth twice a day for 6 months

Sugar pills that look like Apixaban that will be taken by mouth twice a day

Placebo

All-Cause Mortality
Apixaban Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Apixaban Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   0/8 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy *  1/8 (12.50%)  0/8 (0.00%) 
Surgical and medical procedures     
Hospitalization *  1/8 (12.50%)  0/8 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apixaban Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   0/8 (0.00%) 
Cardiac disorders     
Sickle Cell Crisis *  1/8 (12.50%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Sickle Cell Crisis *  1/8 (12.50%)  0/8 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nirmish Shah, MD
Organization: Duke University
Phone: 919-668-5178
EMail: nirmish.shah@duke.edu
Layout table for additonal information
Responsible Party: Nirmish Shah, Duke University
ClinicalTrials.gov Identifier: NCT02179177    
Other Study ID Numbers: Pro00048953
First Submitted: June 27, 2014
First Posted: July 1, 2014
Results First Submitted: February 24, 2020
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020