Tapered Warfarin or Interrupted Warfarin With Heparin Bridging for Pacemaker or Defibrillator Implantation (PACEBRIDGE)
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|ClinicalTrials.gov Identifier: NCT02094157|
Recruitment Status : Terminated (Change of practice made further recruitment impossible)
First Posted : March 21, 2014
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrhythmias Hemorrhage Thromboembolism||Drug: Tapered warfarin regimen Drug: Bridged regimen Low-molecular-weight heparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Open-Label Randomized Control Trial of Pre-Operative Low Molecular Weight Heparin Versus Tapered Warfarin as Bridging Therapy for Patients With Implantation of Pacemaker or Defibrillator|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||March 2014|
Active Comparator: Bridged regimen
Bridged regimen Warfarin therapy is stopped for 5 days before surgery and restarted in the evening of surgery at double the usual dose for two days. Bridging with low-molecular-weight heparin at therapeutic dose is given for 2½ days before surgery.
Drug: Bridged regimen Low-molecular-weight heparin
This intervention is assigned to the active control arm - Bridged regimen
Other Name: Low-molecular-weight heparin
Experimental: Tapered warfarin regimen
Tapered warfarin regimen Warfarin is given at half the usual maintenance dose for 3-6 days before surgery depending on the INR at the baseline visit. A double dose is given in the evening of surgery. No bridging with LMWH is used.
Drug: Tapered warfarin regimen
This intervention is assigned to the experimental arm - Tapered warfarin regimen
Other Name: Half dose warfarin
- Pocket hematoma [ Time Frame: 1 month ]Pocket hematoma is defined as palpable swelling of the pacemaker or defibrillator pocket exceeding the size of the generator.
- Major bleeding [ Time Frame: 1 month ]Fatal bleeding OR Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome OR Bleeding causing a fall in hemoglobin level of 20 g·L-1 (1.24 mmol·L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.
- Thromboembolism [ Time Frame: 1 month ]Arterial thromboembolism, consisting of one or more of the following: stroke (ischemic or hemorrhagic), transient ischemic attack, systemic embolism to a limb or viscus, thrombosis of a mechanical or native heart valve, or thrombosis of a cardiac chamber. OR Venous thromboembolism that is symptomatic AND for deep vein thrombosis is verified by ultrasound, venography or computed tomography; for pulmonary embolism is verified by ventilation-perfusion lung scan, spiral computed tomography or pulmonary angiography.
- Preoperative reversal with vitamin K [ Time Frame: 1 day ]Patients with International Normalized Ratio (INR) above 1.7 the day before surgery require correction of the coagulopathy with vitamin K to allow for surgery.
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): NCT02094157
|Hamilton Health Sciences-General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Sam Schulman, MD, PhD||McMaster University|