Overview

AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis

Status:
Terminated
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborators:
Duke Clinical Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Anticoagulants
Warfarin
Criteria
Inclusion Criteria:

- 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:

1. Worsened dyspnea

2. FVC decreased by >=10% predicted OR

3. DLCO decreased by >=10% absolute OR

4. Reduction of oxygenation saturation >= 5% with or without exertion on a constant
oxygen (02) administration

5. Worsened radiographic findings (chest x-ray or high-resolution computed
tomography)

Exclusion Criteria:

- 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:

1. 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.

2. Subject has a transplanted organ requiring immunosuppression

3. 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).

4. 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:

1. Current anticoagulation therapy with warfarin

2. Increased risk of bleeding (e.g. uncorrectable inherited or acquired bleeding
disorder)

3. Platelet count < 100,000 or hematocrit < 30% or > 55%

4. History of severe gastrointestinal bleeding within 6 months of screening

5. History of cerebral vascular accident (CVA) within 6 months of screening

6. High risks of falls as judged by the PI

7. Surgery or major trauma within the past 30 days

8. Pregnancy, or lack of use of birth control method in women of childbearing age

9. Any condition that, in the determination of the PI, is likely to require
anticoagulation therapy during the study.

10. 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.)

11. Patients on prasugrel are excluded. Prasugrel must be stopped for one week prior
to starting study drug.