NCT01810237

Brief Summary

Research Questions:

  1. 1.Does using dabigatran bridging result in consistent therapeutic anticoagulation? What percentage of patients will become subtherapeutic on warfarin once dabigatran is stopped?
  2. 2.What is the incidence of bleeding events with the use of dabigatran overlapped with warfarin for bridging?
  3. 3.What is the cost benefit of using dabigatran instead of dalteparin for bridging anticoagulation?

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

February 28, 2013

Last Update Submit

January 30, 2017

Conditions

Venous Thromboses

Outcome Measures

Primary Outcomes (1)

  • Validation of a novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy

    1 Year.

Study Arms (1)

Dabigtran instead of LMWH for perioperative bridging.

EXPERIMENTAL
Drug: Dabigatran.

Interventions

Dabigatran.DRUG

Dabigatran will be used instead of LMWH for anticoagulation bridging.

Dabigtran instead of LMWH for perioperative bridging.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low risk status VTE
  • Chronic warfarin therapy of at least 12 months duration with target INR of 2.0-3.0

You may not qualify if:

  • Increased risk of bleeding: bleeding requiring transfusion in last 12 months, history of hemorrhagic stroke or intracranial hemorrhage, recent gastrointestinal bleeding {\<6 months}, history of a bleeding disorder
  • Pregnant, breastfeeding or planning to become pregnant or breastfeed
  • Inhibitors allergy/sensitivity to dabigatran etexilate
  • Creatinine Clearance \< 30 mls/min
  • Concomitant treatment with strong P-glycoprotein
  • Known thrombophilia including Factor V Leiden mutation, prothrombin gene mutation, antithrombin deficiency, protein C deficiency, protein S deficiency, and antiphospholipid antibody syndrome
  • Inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD FRCPC

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

January 31, 2017

Record last verified: 2017-01