Idiopathic Pulmonary FibrosisPhase 3ACE-IPFNCT00957242
AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis
A Phase 3 study testing warfarin in people with Idiopathic Pulmonary Fibrosis, run by Duke University at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 22 sitesUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
St. Luke's Hospital
Chesterfield, Missouri, 63017
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Medical and Research Center
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
University of California - Los Angeles
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40425
University of Miami Miller School of Medicine
Miami, Florida, 33136
Vanderbilt University
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520-8057
Tulane University
New Orleans, Louisiana, 70118
Weill Medical College of Cornell University
New York, New York, 10021
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Highland Hospital - University of Rochester Medical Center
Rochester, New York, 14620
University of Utah Health Research Center
Salt Lake City, Utah, 84108
University of California - San Francisco
San Francisco, California, 94110
University of Washington
Seattle, Washington, 98165
About this study
Official title: AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)
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.
Read the 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 sham dose-adjusted placebo. The trial was originally designed as an event-driven study with a treatment period of up to 144 weeks. Given the slow rate of recruitment and higher than anticipated event rates seen in another Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet) trial, the protocol was modified to have a maximum treatment period of 48 weeks after eleven patients were enrolled in the study. Participants were to be seen at screening, baseline, and at 16, 32, and 48 weeks after enrollment.
Outcome measures:
The primary outcome was a composite endpoint based on the time to all-cause mortality; non-elective, non-bleeding hospitalization; or a decrease in the absolute FVC ≥10% from baseline value. Secondary outcome measures included rates of mortality, hospitalization, respiratory-related hospitalization, acute exacerbation, bleeding, cardiovascular events, and changes over time in FVC, six-minute walk test distance, diffusing capacity of lung for carbon monoxide (DLCO), plasma fibrin D-dimer levels, and quality of life (QOL) assessments.
Data Analysis Continuous variables at baseline were expressed as means (standard deviations) and medians (25th and 75th percentiles). Categorical variables at baseline were expressed as counts and percentages. Unadjusted estimates of event rates for time-to-event variables were computed using the Kaplan-Meier estimator with comparisons based on the log-rank test statistic. The primary hypothesis was tested using a Cox proportional hazards regression model, comparing the treatment effect on the primary composite endpoint. Pre-specified covariates in this model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.
Randomization:
Subjects were randomly assigned to study arms in a 1:1 ratio, using a permuted-block design with varying block sizes, to receive either warfarin or matched placebo. Subjects were stratified by clinical center and a DLCO threshold of 35% of predicted. Randomization lists were generated by the study data coordinating center (DCC) and provided to a phone- and web-enabled registration system (Almac Clinical Services, Inc.) that allowed sites to enroll subjects and receive study kits while keeping the study team and subjects blinded to treatment assignment.
INR testing and monitoring:
Study subjects were provided two strengths of warfarin tablets (1 mg and 2.5 mg) or matching placebos. Subjects measured their INR with encrypted meters (INRatio®, Alere, San Diego, CA) at least weekly. Home monitoring was validated by plasma INR measurement at the week 1 and 16 visits. Individual INR meters and test strips were replaced and subjects were reinstructed if meter INR readings varied by more than 30% from the laboratory INR. Efficacy of home INR measures were determined by time-in-target INR range of all patients, calculated on the basis of linear interpolation, 12 after excluding readings taken at baseline, during initial warfarin titration (until INR ≥ 2.0), study drug interruption, or following the discontinuation of study drug.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- warfarin, placebo
- Keywords
- IPF, Warfarin
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
Also called warfarin sodium
Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
placeboDrug
Oral placebo (1mg or 2.5mg)
| Study group | Role | What they receive |
|---|---|---|
| warfarin | Active comparator | Oral warfarin titrated to an international normalization ratio (INR) of 2-3 Receives: Drug: warfarin |
| placebo | Placebo comparator | Oral placebo (1mg or 2.5mg) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity
Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.
Measured: Events up to 48 weeks
Secondary outcomes (11)
All Cause Mortality
Measured: maximum of 48 weeks
Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks
Week-16 change from Baseline
Measured: 16 weeks
All-cause Hospitalizations
Measured: maximum 48 weeks
Bleeding Events
Measured: maximum of 48 weeks
Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
Measured: maximum of 48 weeks
Respiratory-related Hospitalizations
Measured: maximum 48 weeks
Cardiovascular Mortality or Morbidity
Measured at 48 Weeks
Measured: maximum of 48 weeks
Change in 6-minute Walk Distance (6MWD)
The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline).
Measured: Change from baseline to last visit (maximum of 48 weeks)
Total Score St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better).
Measured: Week 16 Change from Baseline
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks
The DLCO measures the partial pressure difference between inspired and expired carbon monoxide.
Measured: Week 48 / Final Visit
Fibrin D-dimer Change From Baseline to 16 Weeks
Biomarker that measures biologic activities in patients as opposed to response.
Measured: maximum of 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Excess of mortality in the treatment group created safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Galen Toews, MD, Study chair, University of MichiganGail Weinmann, MD, Study director, National Heart, Lung, and Blood Institute (NHLBI)Kevin Brown, MD, Principal investigator, National Jewish HealthRob Kaner, MD, Principal investigator, Weill Medical College at Cornell UniversityTalmadge King, MD, Principal investigator, University of California, San FranciscoJoe Lasky, MD, Principal investigator, Tulane University School of MedicineJames Loyd, MD, Principal investigator, Vanderbilt UniversityFernando Martinez, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957242
- Sponsor's protocol ID
- Pro00017156
- Other IDs
- 5U10HL080413-05, 671
- Acronym
- ACE-IPF
- Status last verified
- Apr 2013
- First submitted
- 10 Aug 2009
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
PubMed 35688625Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D, Kaner RJ; IPFnet Investigators. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest. 2015 Oct;148(4):1034-1042. doi: 10.1378/chest.14-2889.
PubMed 26111071Durheim MT, Collard HR, Roberts RS, Brown KK, Flaherty KR, King TE Jr, Palmer SM, Raghu G, Snyder LD, Anstrom KJ, Martinez FJ; IPFnet investigators. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med. 2015 May;3(5):388-96. doi: 10.1016/S2213-2600(15)00093-4. Epub 2015 Apr 15.
PubMed 25890798Noth I, Anstrom KJ, Calvert SB, de Andrade J, Flaherty KR, Glazer C, Kaner RJ, Olman MA; Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet). A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2012 Jul 1;186(1):88-95. doi: 10.1164/rccm.201202-0314OC. Epub 2012 May 3.
PubMed 22561965
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)
- ClinicalTrials.gov ID
- NCT00957242
- Acronym / sponsor ID
- ACE-IPF / Pro00017156
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, Warfarin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Excess of mortality in the treatment group created safety concerns.
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke Clinical Research Institute
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 21 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 sham dose-adjusted placebo. The trial was originally designed as an event-driven study with a treatment period of up to 144 weeks. Given the slow rate of recruitment and higher than anticipated event rates seen in another Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet) trial, the protocol was modified to have a maximum treatment period of 48 weeks after eleven patients were enrolled in the study. Participants were to be seen at screening, baseline, and at 16, 32, and 48 weeks after enrollment.
Outcome measures:
The primary outcome was a composite endpoint based on the time to all-cause mortality; non-elective, non-bleeding hospitalization; or a decrease in the absolute FVC ≥10% from baseline value. Secondary outcome measures included rates of mortality, hospitalization, respiratory-related hospitalization, acute exacerbation, bleeding, cardiovascular events, and changes over time in FVC, six-minute walk test distance, diffusing capacity of lung for carbon monoxide (DLCO), plasma fibrin D-dimer levels, and quality of life (QOL) assessments.
Data Analysis Continuous variables at baseline were expressed as means (standard deviations) and medians (25th and 75th percentiles). Categorical variables at baseline were expressed as counts and percentages. Unadjusted estimates of event rates for time-to-event variables were computed using the Kaplan-Meier estimator with comparisons based on the log-rank test statistic. The primary hypothesis was tested using a Cox proportional hazards regression model, comparing the treatment effect on the primary composite endpoint. Pre-specified covariates in this model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.
Randomization:
Subjects were randomly assigned to study arms in a 1:1 ratio, using a permuted-block design with varying block sizes, to receive either warfarin or matched placebo. Subjects were stratified by clinical center and a DLCO threshold of 35% of predicted. Randomization lists were generated by the study data coordinating center (DCC) and provided to a phone- and web-enabled registration system (Almac Clinical Services, Inc.) that allowed sites to enroll subjects and receive study kits while keeping the study team and subjects blinded to treatment assignment.
INR testing and monitoring:
Study subjects were provided two strengths of warfarin tablets (1 mg and 2.5 mg) or matching placebos. Subjects measured their INR with encrypted meters (INRatio®, Alere, San Diego, CA) at least weekly. Home monitoring was validated by plasma INR measurement at the week 1 and 16 visits. Individual INR meters and test strips were replaced and subjects were reinstructed if meter INR readings varied by more than 30% from the laboratory INR. Efficacy of home INR measures were determined by time-in-target INR range of all patients, calculated on the basis of linear interpolation, 12 after excluding readings taken at baseline, during initial warfarin titration (until INR ≥ 2.0), study drug interruption, or following the discontinuation of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warfarin | Active comparator | Drug: warfarinOral warfarin titrated to an international normalization ratio (INR) of 2-3 |
| placebo | Placebo comparator | Drug: placeboOral placebo (1mg or 2.5mg) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (23 listed)
- 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:
- Estimated life expectancy < 12 months due to a non-pulmonary cause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warfarinAlso: warfarin sodiumOral warfarin (1mg or 2.5mg) titrated to an INR of 2-3. | Drug | warfarin |
| placeboOral placebo (1mg or 2.5mg) | Drug | placebo |
Primary outcome
Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity
Time frame: Events up to 48 weeks
Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.
11 secondary outcomes
All Cause Mortality
Time frame: maximum of 48 weeks
Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks
Time frame: 16 weeks
All-cause Hospitalizations
Time frame: maximum 48 weeks
Bleeding Events
Time frame: maximum of 48 weeks
Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
Time frame: maximum of 48 weeks
Respiratory-related Hospitalizations
Time frame: maximum 48 weeks
Cardiovascular Mortality or Morbidity
Time frame: maximum of 48 weeks
Change in 6-minute Walk Distance (6MWD)
Time frame: Change from baseline to last visit (maximum of 48 weeks)
Total Score St. George's Respiratory Questionnaire (SGRQ)
Time frame: Week 16 Change from Baseline
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks
Time frame: Week 48 / Final Visit
Fibrin D-dimer Change From Baseline to 16 Weeks
Time frame: maximum of 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35688625Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
- Derived from this study: PubMed 26111071Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D, Kaner RJ; IPFnet Investigators. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest. 2015 Oct;148(4):1034-1042. doi: 10.1378/chest.14-2889.
- Derived from this study: PubMed 25890798Durheim MT, Collard HR, Roberts RS, Brown KK, Flaherty KR, King TE Jr, Palmer SM, Raghu G, Snyder LD, Anstrom KJ, Martinez FJ; IPFnet investigators. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med. 2015 May;3(5):388-96. doi: 10.1016/S2213-2600(15)00093-4. Epub 2015 Apr 15.
- Derived from this study: PubMed 22561965Noth I, Anstrom KJ, Calvert SB, de Andrade J, Flaherty KR, Glazer C, Kaner RJ, Olman MA; Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet). A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2012 Jul 1;186(1):88-95. doi: 10.1164/rccm.201202-0314OC. Epub 2012 May 3.
- IPFnet Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen Toews, MD study chair
University of Michigan
Gail Weinmann, MD study director
National Heart, Lung, and Blood Institute (NHLBI)
Kevin Brown, MD principal investigator
National Jewish Health
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing warfarin in people with Idiopathic Pulmonary Fibrosis, run by Duke University at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity (time frame: Events up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957242, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.