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Trial record 4 of 293 for:    warfarin AND anticoagulation

Anticoagulation For Pulmonary Hypertension in 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: NCT01036802
Recruitment Status : Terminated (Difficulty in accruing subjects)
First Posted : December 21, 2009
Results First Posted : February 21, 2014
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Interventions Drug: Warfarin
Drug: Placebo
Enrollment 3
Recruitment Details Patients were randomized 1:1 to receive anticoagulation with warfarin or placebo after evaluation in the clinical and translational research center. Enrollment began in January 2010 and ended in September 2012 due to poor patient accrual.
Pre-assignment Details Following patient identification, an open-label run-in period was begun to ensure patient doses of warfarin could be titrated to a stable level that achieved an international normalized ratio between 2.0 and 3.0 without exceeding a dose of 15 mg per day and to exclude patients with a level of compliance less than 80% (based on pill counts).
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin Patients were randomized to placebo
Period Title: Overall Study
Started 2 1
Completed 2 1 [1]
Not Completed 0 0
[1]
Patient was taken off study after 7 months as she required hip replacement surgery.
Arm/Group Title Warfarin Placebo Total
Hide Arm/Group Description Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin Patients were randomized to placebo Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
29.5  (12.02) 53 37.3  (16.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Effect of Anticoagulation on Pulmonary Artery Systolic Pressure Was Obtained by Doppler Echocardiography
Hide Description We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.
Time Frame Measurements were obtained at Screening, and at Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 2 1
Mean (Full Range)
Unit of Measure: mm Hg
Screening (n=2,1)
41.3
(39 to 43.6)
43.6
(43.6 to 43.6)
Month 3 (n=1,1)
39.2
(39.2 to 39.2)
39.2
(39.2 to 39.2)
Month 6 (n=2,1)
41.3
(39.2 to 43.6)
43.6
(43.6 to 43.6)
Month 9 (n=1,1)
46
(46 to 46)
37
(37 to 37)
Month 12 (n=1,1)
46
(46 to 46)
37
(37 to 37)
2.Secondary Outcome
Title 6-minute Walk Test
Hide Description We evaluated the distance walked over 6 minutes. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.
Time Frame Measurements were obtained at Screening, Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were on placebo
Overall Number of Participants Analyzed 2 1
Mean (Full Range)
Unit of Measure: feet
Screen (n=1,1)
1381
(1381 to 1381)
1135
(1135 to 1135)
Month 3 (n=1,1)
1275
(1275 to 1275)
1135
(1135 to 1135)
Month 6 (n=1,1)
1275
(1275 to 1275)
1075
(1075 to 1075)
Month 9 (n=1,1)
1275
(1275 to 1275)
1075
(1075 to 1075)
Month 12 (n=1,1)
1275
(1275 to 1275)
1075
(1075 to 1075)
3.Secondary Outcome
Title Thrombin Generation
Hide Description We evaluated the effect of warfarin on a plasma measure of thrombin generation (thrombin-antithrombin complex)
Time Frame Measurements were obtained at Screening, and at Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed due to the early termination of the study and the very small number of participating subjects.
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Platelet Activation
Hide Description We evaluated the effect of anticoagulation with warfarin on platelet activation assessed by measuring plasma levels of soluble CD40 ligand
Time Frame Measurements were obtained at Screening, Prior to Run-in, and at Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed due to the early termination of the study and the very small number of participating subjects.
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Endothelial Activation
Hide Description We assessed the effect of warfarin on plasma measures of endothelial activation (soluble vascular cell adhesion molecule-1)
Time Frame Measurements were obtained at Screening, and at Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
As the number of subjects studied were very few, requiring discontinuation of the study, evaluation of endothelial activation was not performed.
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title All-cause Mortality
Hide Description We assessed the effect of warfarin on mortality in the study subjects
Time Frame Assessment was obtained until completion of study at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title Major and Minor Bleeding Complications
Hide Description We evaluated the safety of warfarin by evaluating for major and minor bleeding complications in study subjects
Time Frame Evaluations were obtained at Screening, and at Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description:
Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
Patients were randomized to placebo
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: participants
Screen 0 0
Month 3 0 0
Month 6 0 0
Month 9 0 0
Month 12 0 0
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin Placebo
Hide Arm/Group Description Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin Patients were randomized to placebo
All-Cause Mortality
Warfarin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      0/1 (0.00%)    
Blood and lymphatic system disorders     
Delayed hemolytic transfusion reaction  [1]  1/2 (50.00%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject was transfused following hospitalization for a pain crisis, but was readmitted 1 week following discharge with findings consistent with a delayed hemolytic transfusion reaction.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warfarin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)    
This study was terminated early due to difficulty in accruing subjects.
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: Kenneth I. Ataga, MD
Organization: University of North Carolina, Chapel Hill
Phone: 919-843-7708
EMail: kataga@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01036802     History of Changes
Other Study ID Numbers: 09-1596
R01HL094592-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2009
First Posted: December 21, 2009
Results First Submitted: July 3, 2013
Results First Posted: February 21, 2014
Last Update Posted: May 9, 2016