Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)

This study has been terminated.
(Excess of mortality in the treatment group created safety concerns.)
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00957242
First received: August 10, 2009
Last updated: July 14, 2014
Last verified: April 2013
Results First Received: March 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: warfarin
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Oral placebo (1mg or 2.5mg)

placebo : Oral placebo (1mg or 2.5mg)

Warfarin

Oral warfarin titrated to an INR of 2-3

warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.


Participant Flow:   Overall Study
    Placebo   Warfarin
STARTED   73   72 
COMPLETED   73   72 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Oral placebo (1mg or 2.5mg)

placebo : Oral placebo (1mg or 2.5mg)

Warfarin

Oral warfarin titrated to an INR of 2-3

warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.

Total Total of all reporting groups

Baseline Measures
   Placebo   Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   72   145 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   31   22   53 
>=65 years   42   50   92 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.7  (7.4)   67.3  (7.1)   67  (7.3) 
Gender 
[Units: Participants]
     
Female   15   24   39 
Male   58   48   106 
Region of Enrollment 
[Units: Participants]
     
United States   73   72   145 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity   [ Time Frame: Events up to 48 weeks ]

2.  Secondary:   All Cause Mortality   [ Time Frame: maximum of 48 weeks ]

3.  Secondary:   Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

4.  Secondary:   All-cause Hospitalizations   [ Time Frame: maximum 48 weeks ]

5.  Secondary:   Bleeding Events   [ Time Frame: maximum of 48 weeks ]

6.  Secondary:   Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)   [ Time Frame: maximum of 48 weeks ]

7.  Secondary:   Respiratory-related Hospitalizations   [ Time Frame: maximum 48 weeks ]

8.  Secondary:   Cardiovascular Mortality or Morbidity   [ Time Frame: maximum of 48 weeks ]

9.  Secondary:   Change in 6-minute Walk Distance (6MWD)   [ Time Frame: Change from baseline to last visit (maximum of 48 weeks) ]

10.  Secondary:   Total Score St. George's Respiratory Questionnaire (SGRQ)   [ Time Frame: Week 16 Change from Baseline ]

11.  Secondary:   Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks   [ Time Frame: Week 48 / Final Visit ]

12.  Secondary:   Fibrin D-dimer Change From Baseline to 16 Weeks   [ Time Frame: maximum of 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Imre Noth, MD, Associate Professor of Medicine
Organization: University of Chicago Hospital
phone: 773-834-1832
e-mail: 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     History of Changes
Other Study ID Numbers: Pro00017156
5U10HL080413-05 ( US NIH Grant/Contract Award Number )
671
Study First Received: August 10, 2009
Results First Received: March 4, 2013
Last Updated: July 14, 2014
Health Authority: United States: Federal Government