Study:
AntiCoagulant Effectiveness in Idiopathic Pulmonary Fibrosis (ACE-IPF)
Rationale:
n/a
Purpose:
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.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Idiopathic Pulmonary Fibrosis |
Drug: warfarin
Drug: placebo |
Phase 3 |
Verified by
National Heart, Lung, and Blood Institute (NHLBI)
December, 2011
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov identifier: NCT00957242
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Galen Toews, MD., Study Chair
Gail Weinmann, MD., Study Director
Kevin Brown, MD., Principal Investigator
Rob Kaner, MD., Principal Investigator
Talmadge King, MD., Principal Investigator
Joe Lasky, MD., Principal Investigator
James Loyd, MD., Principal Investigator
Fernando Martinez, MD., Principal Investigator
Imre Noth, MD., Principal Investigator
Ganesh Raghu, MD., Principal Investigator
Jesse Roman, MD., Principal Investigator
Jay Ryu, MD., Principal Investigator
Joseph Lynch, MD., Principal Investigator
Kevin Anstrom, PhD., Principal Investigator
Joao deAndrade, MD., Principal Investigator
Jeffrey Chapman, MD., Principal Investigator
Lake Morrison, MD., Principal Investigator
Michael Kallay, MD., Principal Investigator
Steven Sahn, MD., Principal Investigator
Marilyn Glassberg, MD., Principal Investigator
Milton Rossman, MD., Principal Investigator
John Fitzgerald, MD., Principal Investigator
Mary Beth Scholand, MD., Principal Investigator
Neil Ettinger, MD., Principal Investigator
Danielle Antin-Ozerkis, MD., Principal Investigator