AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)
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| ClinicalTrials.gov Identifier: NCT00957242 |
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Recruitment Status :
Terminated
(Excess of mortality in the treatment group created safety concerns.)
First Posted : August 12, 2009
Results First Posted : October 21, 2013
Last Update Posted : July 23, 2014
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Sponsor:
Duke University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Idiopathic Pulmonary Fibrosis |
| Interventions |
Drug: warfarin Drug: placebo |
| Enrollment | 145 |
Participant Flow
| Recruitment Details | Subjects were randomized at 25 U.S. sites in a 1:1 ratio to warfarin or matching placebo for a planned treatment period of 48 weeks. International normalized ratios (INR) were monitored using encrypted home point-of-care devices that allowed blinding of study therapy. |
| Pre-assignment Details |
| Arm/Group Title | Placebo | Warfarin |
|---|---|---|
 Arm/Group Description |
Oral placebo (1mg or 2.5mg) placebo : Oral placebo (1mg or 2.5mg) |
Oral warfarin titrated to an INR of 2-3 warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3. |
| Period Title: Overall Study | ||
| Started | 73 | 72 |
| Completed | 73 | 72 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | Warfarin | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Oral placebo (1mg or 2.5mg) placebo : Oral placebo (1mg or 2.5mg) |
Oral warfarin titrated to an INR of 2-3 warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 73 | 72 | 145 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 73 participants | 72 participants | 145 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
31 42.5%
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22 30.6%
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53 36.6%
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| >=65 years |
42 57.5%
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50 69.4%
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92 63.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 73 participants | 72 participants | 145 participants | |
| 66.7 (7.4) | 67.3 (7.1) | 67 (7.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 73 participants | 72 participants | 145 participants | |
| Female |
15 20.5%
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24 33.3%
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39 26.9%
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| Male |
58 79.5%
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48 66.7%
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106 73.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 73 participants | 72 participants | 145 participants |
| 73 | 72 | 145 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Imre Noth, MD, Associate Professor of Medicine |
| Organization: | University of Chicago Hospital |
| Phone: | 773-834-1832 |
| EMail: | inoth@medicine.bsd.uchicago.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00957242 |
| Other Study ID Numbers: |
Pro00017156 5U10HL080413-05 ( U.S. NIH Grant/Contract ) 671 |
| First Submitted: | August 10, 2009 |
| First Posted: | August 12, 2009 |
| Results First Submitted: | March 4, 2013 |
| Results First Posted: | October 21, 2013 |
| Last Update Posted: | July 23, 2014 |