Anticoagulant, Perioperative Clinical Trial
— StimAODOfficial title:
Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation
| NCT number | NCT03879473 |
| Other study ID # | CV185-614 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2019 |
| Est. completion date | March 2020 |
Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or
implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of
patients undergoing cardiac device implantation receive long-term anticoagulation therapy,
that increases the incidence of pocket hematoma with potential serious consequences for
patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited
data currently exist on the perioperative management of DOAC-treated patients undergoing
cardiac device implantation and the optimal strategy remains unclear. Especially, the time of
DOAC resumption after the procedure is controversial.
We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in
DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed
DOAC resumption > 48 hours following the procedure will reduce pocket hematoma incidence
compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We
propose here an observational multicentre national study to find out the optimal strategy.
| Status | Recruiting |
| Enrollment | 680 |
| Est. completion date | March 2020 |
| Est. primary completion date | February 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment - undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy - informed |
| Country | Name | City | State |
|---|---|---|---|
| France | HEGP | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Necker Enfants Malades |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of patients with clinically significant pocket hematoma | hematoma requiring reoperation, and/or resulting in prolongation of hospitalization, and/or requiring interruption of all anticoagulation. | 30 +/- 5 days | |
| Secondary | number of patients with thromboembolic event | transient ischemic attack, stroke, peripheral embolus, venous thromboembolism | 30 +/- 5 days |