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Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

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ClinicalTrials.gov Identifier: NCT03196349
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 22, 2017
Results First Posted : August 14, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Venous Thromboembolism
Interventions Drug: Warfarin
Drug: Apixaban 2.5 MG
Drug: Rivaroxaban 10 MG
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Period Title: Overall Study
Started 17 14 13
Completed 0 0 0
Not Completed 17 14 13
Reason Not Completed
Did not receive study drug             0             1             2
No data entered             2             4             0
Study Terminated early             15             9             11
Arm/Group Title Warfarin Apixaban Rivaroxaban Total
Hide Arm/Group Description

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Total of all reporting groups
Overall Number of Baseline Participants 16 13 12 41
Hide Baseline Analysis Population Description
44 subjects were randomized yet only 31 were on study drug by the 1 month telephone follow up. Due to the study being stopped early some of the data was outstanding in the database which is why the numbers do not add up to 44 in all of the categories.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 12 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  68.8%
5
  38.5%
11
  91.7%
27
  65.9%
>=65 years
5
  31.3%
8
  61.5%
1
   8.3%
14
  34.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 12 participants 41 participants
Female
4
  25.0%
3
  23.1%
2
  16.7%
9
  22.0%
Male
12
  75.0%
10
  76.9%
10
  83.3%
32
  78.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 12 participants 11 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   9.1%
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  12.5%
1
   8.3%
2
  18.2%
5
  12.8%
White
14
  87.5%
10
  83.3%
8
  72.7%
32
  82.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   8.3%
0
   0.0%
1
   2.6%
[1]
Measure Analysis Population Description: In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 13 participants 12 participants 41 participants
10 7 9 26
Canada Number Analyzed 16 participants 13 participants 12 participants 41 participants
6 6 3 15
1.Primary Outcome
Title Number of Subjects With Clinically Relevant Bleeding Events
Hide Description Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
44 subjects were randomized but analysis was only done on participants that had started therapy by the 1 month telephone visit
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 14 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Recurrent Venous Thromboembolism (VTE)
Hide Description Primary efficacy outcome of recurrent VTE
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   7.1%
0
   0.0%
3.Other Pre-specified Outcome
Title Number of Subjects Experiencing Major Bleeding
Hide Description Major bleeding
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
4.Other Pre-specified Outcome
Title Number of Subjects Experiencing Clinically Relevant Non-major Bleeding
Hide Description Clinically relevant non-major bleeding
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Other Pre-specified Outcome
Title Number of Subjects With Premature Termination of Study Medication
Hide Description Premature termination of study medication
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
6.Other Pre-specified Outcome
Title Number of Subjects Experiencing All-cause Mortality
Hide Description All cause mortality
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
7.Other Pre-specified Outcome
Title Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)
Hide Description MI, ischemic stroke, peripheral arterial embolism
Time Frame Randomization to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description:

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

Overall Number of Participants Analyzed 17 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.9%
0
   0.0%
0
   0.0%
Time Frame Up to 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin Apixaban Rivaroxaban
Hide Arm/Group Description

Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3

Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3

Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily

Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily

Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily

All-Cause Mortality
Warfarin Apixaban Rivaroxaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
Warfarin Apixaban Rivaroxaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warfarin Apixaban Rivaroxaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/8 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Ortel
Organization: Duke University
Phone: 919-684-5350 ext 3
EMail: thomas.ortel@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03196349    
Other Study ID Numbers: Pro00077510
First Submitted: June 20, 2017
First Posted: June 22, 2017
Results First Submitted: July 26, 2019
Results First Posted: August 14, 2019
Last Update Posted: December 13, 2019