Phase 3
Completed N=168
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
Cardiac Disease
Source: ClinicalTrials.gov NCT03395639 ↗
Enrolled (actual)
168
Serious AEs
8.7%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period — 1; 1; 0; 0 Participants
◆ Published Evidence
Established
59citations · ~15 / year
Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease.
Summary
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).
All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.
The study will find out if edoxaban is safer and more effective than the standard of care.
Linked Publications
-
Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period |
1; 1; 0; 0; 4; 2 | — |
| SECONDARY Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period |
0; 0 | — |
| SECONDARY Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period |
0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Bleeding Events During the Extension Period |
1; 1; 4 | — |
| SECONDARY Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period |
4; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period |
— | — |
| SECONDARY Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis
Either one of the following:
- a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).
OR
- a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.
Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.
- Is a male or female child between 1 and 99th percentile plus 5 mmHg
- Has thrombocytopenia or life expectancy less than three months
- Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy
- Is pregnant or breastfeeding
- Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)
- Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol
Data sourced from ClinicalTrials.gov (NCT03395639) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.