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Reinitiation of Anticoagulation After Temporary Withdrawal of Vitamin K Antagonist (DOSIDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01348074
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sam Schulman, McMaster University

Tracking Information
First Submitted Date  ICMJE May 3, 2011
First Posted Date  ICMJE May 5, 2011
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Proportion of patients with INR back in therapeutic range Day 5 or Day 10 [ Time Frame: Day 5-10 ]
Proportion of patients with INR 2.0-3.0 on Day 5 or Day 10 (day of invasive procedure defined as Day 1)
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
  • Proportion of patients with INR back in therapeutic range Day 5 [ Time Frame: Day 5 ]
    Proportion of patients with INR 2.0-3.0 on Day 5 (day of invasive procedure defined as Day 1)
  • Proportion of patients with INR in the therapeutic range day 10 [ Time Frame: 10 Days ]
    Proportion of patients with INR 2.0-3.0 on Day 10 (day of invasive procedure defined as Day 1)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
  • Thromboembolic events [ Time Frame: 30 days ]
    Objectively verified arterial or venous thromboembolic events
  • Major bleeding events [ Time Frame: 30 days ]
    Defined by the ISTH criteria of 2010
  • Minor bleeding events [ Time Frame: 30 days ]
    Any bleeding requiring medical attention but not fulfilling the criteria of Major bleeding
  • Laboratory parameters of hypercoagulability [ Time Frame: 10 days ]
    Quantitative D-dimer and Thrombin Generation performed in a subset at day of procedure, day 5 and 10 to identify abnormal rise.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reinitiation of Anticoagulation After Temporary Withdrawal of Vitamin K Antagonist
Official Title  ICMJE Phase II Study of Double Versus Single Reinitiation Dose of Warfarin After Interruption for Surgery
Brief Summary It is not known how to best restart warfarin after temporary withdrawal. Participants will be randomized to two groups. Group 1 will restart warfarin at their usual maintenance dose, group 2 will restart warfarin at double their maintenance dose for two days followed by their usual maintenance dose. The main outcome parameter will be the number of patients who are back in therapeutic INR (international normalized ratio) range 4, and 9 days after restarting anticoagulation with warfarin. Thromboembolic and/or bleeding events will be recorded as additional parameters. These data will be collected by a standardized telephone interview at 1 month. In addition, the investigators will evaluate a possible prothrombotic state by measuring the potential of thrombin generation and D-dimers in the subset of patients visiting HHS-General Hospital for their INR tests.
Detailed Description We will investigate if it is feasible to use double maintenance dose for the first two administrations of vitamin K antagonists when these drugs were temporarily interrupted and thus keep the time of an increased risk of thromboembolism and duration of "bridging" at a minimum. The control group will consist of patients who resume vitamin K antagonists at their usual maintenance dose. The aim of the study is to establish how to best restart anticoagulation with vitamin K antagonists after temporal withdrawal of these drugs. The main outcome parameter will be the proportion of patients who are back to a therapeutic international normalized ratio (INR) ratio at certain days after restarting vitamin K antagonists. Two additional parameters will be evaluated: Firstly, bleeding and thromboembolic complications will be reported and secondly, a possible prothrombotic state, measured as an elevation of D-dimer, at the initiation of anticoagulation will be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Venous Thromboembolism
  • Heart Valve Disease
  • Surgery
Intervention  ICMJE Drug: Double dose
For each individual the dose on Day 1 and Day 2 will be twice the one normally taken
Other Name: Loading dose
Study Arms  ICMJE
  • Experimental: Double dose
    Re-initiation with warfarin at twice the usual maintenance dose the first 2 days, then maintenance dose.
    Intervention: Drug: Double dose
  • No Intervention: Usual maintenance dose
    Usual maintenance dose from Day 1, i.e. no postoperative loading dose.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
104
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current treatment with warfarin
  • Need for temporary interruption for invasive procedure or surgery

Exclusion Criteria:

  • Need for post-operative hospitalization more than one day
  • Participation in another clinical trial
  • No consent given
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01348074
Other Study ID Numbers  ICMJE HGH20090520
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sam Schulman, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sam Schulman, MD, PhD McMaster University
PRS Account McMaster University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP