AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

DRUG

warfarin

Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.

DRUG

placebo

Oral placebo (1mg or 2.5mg)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Duke Clinical Research Institute

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Galen Toews, MD · University of Michigan

• Gail Weinmann, MD · National Heart, Lung, and Blood Institute (NHLBI)

• Kevin Brown, MD · National Jewish Health

• Rob Kaner, MD · Weill Medical College at Cornell University

• Talmadge King, MD · University of California, San Francisco

• Joe Lasky, MD · Tulane University School of Medicine

• James Loyd, MD · Vanderbilt University

• Fernando Martinez, MD · University of Michigan

• Imre Noth, MD · University of Chicago

• Ganesh Raghu, MD · University of Washington

• Jesse Roman, MD · Emory University

• Jay Ryu, MD · Mayo Clinic

• Joseph Lynch, MD · University of California, Los Angeles

• Kevin Anstrom, PhD · Duke University

• Joao deAndrade, MD · University of Alabama at Birmingham

• Jeffrey Chapman, MD · The Cleveland Clinic

• Lake Morrison, MD · Duke University

• Michael Kallay, MD · Highland Hospital

• Steven Sahn, MD · Medical University of South Carolina

• Marilyn Glassberg, MD · University of Miami

• Milton Rossman, MD · University of Pennsylvania

• John Fitzgerald, MD · University of Texas

• Mary Beth Scholand, MD · University of Utah

• Neil Ettinger, MD · St. Luke's Hospital

• Danielle Antin-Ozerkis, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-07-31

Completion

2011-07-31

Countries

• United States

Study Locations