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Cardiac ArrhythmiasPhase 3PACEBRIDGENCT02094157

Tapered Warfarin or Interrupted Warfarin With Heparin Bridging for Pacemaker or Defibrillator Implantation

A Phase 3 study testing Tapered warfarin regimen and Bridged regimen Low-molecular-weight heparin in people with Cardiac Arrhythmias and Hemorrhage, run by McMaster University at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Approximately 2 million patients in North America are currently treated with the blood thinner warfarin. These patients have every year more than 200,000 invasive procedures, for which warfarin must be stopped to avoid bleeding complication. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrhythmias, Hemorrhage, Thromboembolism
What is being tested?
Tapered warfarin regimen and Bridged regimen Low-molecular-weight heparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
2 sitesCanada
Study dates
Dec 2007to Mar 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has been receiving warfarin therapy for at least 1 week and is planned to continue this treatment for at least one month post-procedure
  • The patient will have elective implantation or replacement of a pacemaker or ICD

Who cannot join

  • Age <18 years
  • Previous stroke
  • Stroke risk (CHADS2) score of 0 or 1 in patients with atrial fibrillation as the only indication for anticoagulation
  • Creatinine clearance (CrCl) <30 mL/min
  • Surgery planned for a Monday or a day after a holiday
  • Patient unsuitable for the study as assessed by the investigator (e.g., psychiatric disorder, history of non-compliance)
  • Failure to obtain written consent

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Hamilton Health Sciences-General Hospital

    Hamilton, Ontario, L8L 2X2

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

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

Approximately 2 million patients in North America are currently treated with the blood thinner warfarin. These patients have every year more than 200,000 invasive procedures, for which warfarin must be stopped to avoid bleeding complication. To protect the patient against blood clots and stroke while warfarin is stopped, most physicians today order "bridging" with low-molecular-weight heparin (LMWH). This is another blood thinner and it is injected under the skin during 3 days before the procedure. For implantation of pacemaker or defibrillator (27,000/year in Canada) the "bridging" routines vary a lot.The common "bridging" treatment with LMWH for 3 days before pacemaker surgery causes bleeding in the "pocket" where the pacemaker is placed in about 5%. For comparison, patients not on any blood thinners develop this bleeding in 2% after this surgery. "Pocket bleeding" may require evacuation of the blood collection and may cause infection. "Pocket bleeding" is thus a fairly common and clinically important but rarely a dangerous bleeding complication. It is a suitable safety endpoint in a study of "bridging" of blood thinners. LMWH costs $80-120, for which some patients are not covered. They have to be taught self-injection technique or have a nurse come to their home. The main hypothesis is if patients on blood thinners can be managed more conveniently before and after pacemaker surgery, without injections, without increased risk of pocket bleeding.

Read the detailed description

Patients are recruited from those routinely referred before surgery for adjustment of their blood thinners. Suitable and consenting patients are randomized to one of the two regimens. They will either stop warfarin for 5 days and replace it with injections of LMWH for 3 days before pacemaker or implantable cardioverter defibrillator (ICD) surgery. The other group will have the dose of warfarin reduced to half for 3-6 days before surgery, depending on how thin their blood is. For all patients the degree of blood thinning is checked the day before surgery. If the blood is still to thin, the patient is instructed to take by mouth a dose of vitamin K, provided by us, to reduce the effect of warfarin. After surgery the patients restart warfarin at a double dose for 1 or 2 days to quickly reach the therapeutic effect again. Staff from the Pacemaker or Defibrillator Clinic, unaware of the treatment allocation, examines the patient for bleeding in the implantation pocket before they leave the hospital, and at routine follow-up after 2-3 weeks and 90 days.

Being tested
Tapered warfarin regimen, Bridged regimen Low-molecular-weight heparin
Keywords
Atrial fibrillation, Mechanical heart valve, Stroke, Venous thromboembolism, Hemorrhage
Medical subject headings
Arrhythmias, Cardiac, Hemorrhage, Thromboembolism, Atrial Fibrillation, Stroke, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tapered warfarin regimenDrug

    Also called Half dose warfarin

    This intervention is assigned to the experimental arm - Tapered warfarin regimen

  • Bridged regimen Low-molecular-weight heparinDrug

    Also called Low-molecular-weight heparin

    This intervention is assigned to the active control arm - Bridged regimen

Study groups in NCT02094157
Study groupRoleWhat they receive
Bridged regimenActive comparatorBridged 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.
Receives: Drug: Bridged regimen Low-molecular-weight heparin
Tapered warfarin regimenExperimentalTapered 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.
Receives: Drug: Tapered warfarin regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pocket hematoma

    Pocket hematoma is defined as palpable swelling of the pacemaker or defibrillator pocket exceeding the size of the generator.

    Measured: 1 month

Secondary outcomes (2)

  1. Major bleeding

    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.

    Measured: 1 month

  2. Thromboembolism

    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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startDec 2007
  3. Primary completionNov 2013
  4. Study completionMar 2014

Why it stopped: Change of practice made further recruitment impossible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094157
Sponsor's protocol ID
PB 20080717
Acronym
PACEBRIDGE
Status last verified
Apr 2016
First submitted
19 Mar 2014
Last updated
5 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Schulman S, Healey JS, Douketis JD, Delaney J, Morillo CA. Reduced-dose warfarin or interrupted warfarin with heparin bridging for pacemaker or defibrillator implantation: a randomized trial. Thromb Res. 2014 Oct;134(4):814-8. doi: 10.1016/j.thromres.2014.07.028. Epub 2014 Aug 1.

    PubMed 25127655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapered warfarin regimen and Bridged regimen Low-molecular-weight heparin in people with Cardiac Arrhythmias and Hemorrhage, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change of practice made further recruitment impossible). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pocket hematoma (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02094157, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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