AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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 review and every 16 weeks for 48 weeks. The primary endpoint in the study is the time to either death, non-bleeding/non-elective hospitalization, or a drop of greater than 10% in forced vital capacity (FVC) from baseline.

Key facts

Study ID

NCT00957242

Run by

Duke University

People needed

145

Starts

2009-10-01

Expected to finish

2011-07-01

Last updated by the study team

2014-07-23

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Highland Hospital - University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Health Research Center — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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