AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00957242
• Date of registration: 10/08/2009
• Prospective Registration: Yes
• Primary sponsor: Duke University
• Public title: AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis ACE-IPF
• Scientific title: AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)
• Date of first enrolment: October 2009
• Target sample size: 145
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00957242
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Joe Lasky, MD
• Affiliation: Tulane University School of Medicine

• Name: Talmadge King, MD
• Affiliation: University of California, San Francisco

• Name: Imre Noth, MD
• Affiliation: University of Chicago

• Name: Danielle Antin-Ozerkis, MD
• Affiliation: Yale University

• Name: Jeffrey Chapman, MD
• Affiliation: The Cleveland Clinic

• Name: Fernando Martinez, MD
• Affiliation: University of Michigan

• Name: Milton Rossman, MD
• Affiliation: University of Pennsylvania

• Name: Lake Morrison, MD
• Affiliation: Duke University

• Name: Ganesh Raghu, MD
• Affiliation: University of Washington

• Name: Kevin Anstrom, PhD
• Affiliation: Duke University

• Name: Steven Sahn, MD
• Affiliation: Medical University of South Carolina

• Name: Neil Ettinger, MD
• Affiliation: St. Luke's Hospital

• Name: Jesse Roman, MD
• Affiliation: Emory University

• Name: Joao deAndrade, MD
• Affiliation: University of Alabama at Birmingham

• Name: Mary Beth Scholand, MD
• Affiliation: University of Utah

• Name: Michael Kallay, MD
• Affiliation: Highland Hospital

• Name: Kevin Brown, MD
• Affiliation: National Jewish Health

• Name: Galen Toews, MD
• Affiliation: University of Michigan

• Name: Rob Kaner, MD
• Affiliation: Weill Medical College at Cornell University

• Name: Jay Ryu, MD
• Affiliation: Mayo Clinic

• Name: Gail Weinmann, MD
• Affiliation: National Heart, Lung, and Blood Institute (NHLBI)

• Name: Joseph Lynch, MD
• Affiliation: University of California, Los Angeles

• Name: Marilyn Glassberg, MD
• Affiliation: University of Miami

• Name: John Fitzgerald, MD
• Affiliation: University of Texas

• Name: James Loyd, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: placebo

Drug: warfarin

Primary Outcome(s)

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

Secondary Outcome(s)

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

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

Bleeding Events [Time Frame: maximum of 48 weeks]

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

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

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

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

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

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

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

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

Secondary ID(s)

671

5U10HL080413-05

Pro00017156

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Duke Clinical Research Institute

Results

• Results available: Yes
• Date Posted: 21/10/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00957242