Status:
TERMINATED
AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
This study will test the effectiveness of warfarin in patients with IPF. Approximately 256 patients will be randomized 1:1 to either warfarin or placebo. Patients will return at week 1 for a safety re...
Detailed Description
Study design: ACE-IPF was a double-blind, randomized, placebo-controlled trial of an oral warfarin dose adjusted to an international normalized ratio (INR) response of 2.0 to 3.0, compared with a sha...
Eligibility Criteria
Inclusion
- Diagnosis of IPF
- Age between 35 and 80, inclusive
- Capable of understanding and signing consent
- Progression despite conventional therapy (standard of care). Progression defined as:
- Worsened dyspnea
- FVC decreased by \>=10% predicted OR
- DLCO decreased by \>=10% absolute OR
- Reduction of oxygenation saturation \>= 5% with or without exertion on a constant oxygen (02) administration
- Worsened radiographic findings (chest x-ray or high-resolution computed tomography)
Exclusion
- Current enrollment in another investigational protocol
- Current treatment with an investigational drug (i.e., participating in an active investigational drug protocol) within the previous 4 weeks or 5 times the half-life of the investigational agent, whichever is longer, prior to screening
- Subject is actively listed for lung transplantation at the time of enrollment
- Subjects who will not be able to perform/complete the study, in the judgment of the physician investigator or coordinator, for at least 3 months. For example:
- Subject has current signs or symptoms of severe, progressive or uncontrolled comorbid illnesses such as: renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease, or any laboratory abnormality which would pose/suggest a risk to the subject during participation in the study.
- Subject has a transplanted organ requiring immunosuppression
- History of substance abuse (drugs or alcohol) within the 2 years prior to screening, history of noncompliance to medical regimens, inability or unwillingness to perform INR monitoring, or other condition/circumstance that could interfere with the subject's adherence to protocol requirements (e.g. psychiatric disease, lack of motivation, travel, etc).
- Have any known active malignancy or have a history of malignancy within the previous 2 years (an example of an exception is a non-melanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months) that might increase the risk of bleeding.
- Estimated life expectancy \< 12 months due to a non-pulmonary cause.
- Subject has another respiratory disease that is predominant (as judged by the PI) in addition to IPF.
- Anticoagulation-related exclusions include:
- Current anticoagulation therapy with warfarin
- Increased risk of bleeding (e.g. uncorrectable inherited or acquired bleeding disorder)
- Platelet count \< 100,000 or hematocrit \< 30% or \> 55%
- History of severe gastrointestinal bleeding within 6 months of screening
- History of cerebral vascular accident (CVA) within 6 months of screening
- High risks of falls as judged by the PI
- Surgery or major trauma within the past 30 days
- Pregnancy, or lack of use of birth control method in women of childbearing age
- Any condition that, in the determination of the PI, is likely to require anticoagulation therapy during the study.
- Clopidogrel and aspirin combination therapy for \> 30 days duration is exclusionary.
- (Aspirin monotherapy \[81-325 mg daily\] or clopidogrel monotherapy are acceptable. Combination clopidogrel and aspirin \<=81mg/day for ≤30 days is also acceptable. NSAIDS are discouraged; acetaminophen may be substituted.)
- Patients on prasugrel are excluded. Prasugrel must be stopped for one week prior to starting study drug.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00957242
Start Date
October 1 2009
End Date
July 1 2011
Last Update
July 23 2014
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
University of California - Los Angeles
Los Angeles, California, United States, 90095
3
University of California - San Francisco
San Francisco, California, United States, 94110
4
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206