Reinitiation of Anticoagulation After Temporary Withdrawal of Vitamin K Antagonist (DOSIDO)
|ClinicalTrials.gov Identifier: NCT01348074|
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Venous Thromboembolism Heart Valve Disease Surgery||Drug: Double dose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Double Versus Single Reinitiation Dose of Warfarin After Interruption for Surgery|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Double dose
Re-initiation with warfarin at twice the usual maintenance dose the first 2 days, then maintenance dose.
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
No Intervention: Usual maintenance dose
Usual maintenance dose from Day 1, i.e. no postoperative loading dose.
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348074
|Thrombosis Service, HHS- General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Sam Schulman, MD, PhD||McMaster University|