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Rivaroxaban · 1 trial · 1 indication
Defined as: 1. Hematoma requiring re-operation \- Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome. or 2. Hematoma resulting in prolongation of hospitalization \- Defined as extended hospitalization or rehospitalization for \> 24 hours, post index surgery, primarily due to hematoma. or 3. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for \> or = 24 hours, in response to wound hematoma.
| Arm | Type | Description |
|---|---|---|
| Continued NOAC | EXPERIMENTAL | \- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout |
| Interrupted NOAC | ACTIVE_COMPARATOR | Interrupted Dabigatran: * Discontinue Dabigatran 1 day before surgery if GFR \> 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min * Resume Dabigatran at next regular dose timing \>or = 24 hours after the end of surgery Interrupted Rivaroxaban: * Discontinue Rivaroxaban 1 full day before surgery * Resume Rivaroxaban at next regular dose timing \>or = 24 hours after the end of surgery Interrupted Apixaban: * Discontinue Apixaban 1 full day before surgery * Resume Apixaban at next regular dose timing \>or = 24 hours after the end of surgery |
| Name | Type | Description |
|---|---|---|
| Dabigatran | DRUG | NOAC |
| Rivaroxaban | DRUG | NOAC |
| Apixaban | DRUG | NOAC |
Inclusion Criteria: * any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision) * receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment * non-rheumatic atrial fibrillation and/or atrial flutt...
Rivaroxaban is an investigational small molecule being studied for the treatment of hematoma, a condition involving localized bleeding outside blood vessels. It is in Phase 3 clinical development for this indication. The drug is being evaluated in patients with moderate to high risk of arterial thromboembolic events.
Rivaroxaban is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of hematoma in patients at moderate to high risk of arterial thromboembolic events.
Rivaroxaban is in Phase 3 clinical development for the treatment of hematoma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in any active clinical trials.
Rivaroxaban has one completed Phase 3 clinical trial, identified as NCT01675076. This trial enrolled 663 participants and was conducted in Canada and Israel. The study evaluated a strategy of continued versus interrupted novel oral anti-coagulant at the time of device surgery in patients with moderate to high risk of arterial thromboembolic events.
Rivaroxaban is the generic name for the drug also known as Xarelto. It is being studied for the treatment of hematoma in patients with moderate to high risk of arterial thromboembolic events. The drug is in Phase 3 clinical development and is being developed by Bristol-Myers Squibb Company.