CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,884 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00786474
NCT00786474Phase 3Completed

Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery

Duke University·interventional·Posted Nov 6, 2008·Updated Mar 7, 2016

In Brief

A Phase 3 clinical trial evaluating Placebo and Dalteparin for Arterial Thromboembolic Events and Atrial Fibrillation. Completed, enrolled 1,884 participants across 1 site.

Detailed Summary

Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much bleeding during and after the surgery or procedure. Some doctors prescribe a different blood thinner, one that works more quickly and wears off more quickly, to bridge the gap between starting and stopping warfarin. However, this short-term treatment is expensive, may increase the risk of bleeding, and has not been proven effective. This study will determine whether a bridging blood thinner called dalteparin is helpful or harmful for people with atrial fibrillation who stop taking warfarin in preparation for surgery or a procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2008
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.7 years ago

Interventions

Placebodrug

Normal saline solution, dosage determined by weight, self-administered by patient twice a day

Dalteparindrug

Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day