An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 22
- Primary Endpoint
- Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
Study Overview
Brief Summary
The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.
Patients eligible for the study are patient who experienced a TEE during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation.
All information will collected by medical record review.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with portal vein thrombosis (PVT)
- •Patients with deep vein thrombosis (DVT)
- •Patients with pulmonary embolism (PE)
- •Patients with myocardial infarction (MI)
- •Patients with unstable angina
- •Patients with transient ischemic attack (TIA)
- •Patients with ischemic stroke
- •Patients with other TEE including embolism, thrombosis, phlebitis, and thrombophlebitis at other locations
Exclusion Criteria
- •There are no exclusion criteria for this study
Arms & Interventions
Patients who experienced a thromboembolic event
Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.
Intervention: Eltrombopag (Drug)
Outcomes
Primary Outcomes
Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
Time Frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Evaluation for liver transplant and result of evaluation.
Time Frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Liver transplantation. Patients who experienced a Liver transplantation during study participation.
Time Frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.
Time Frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.
Time Frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Secondary Outcomes
No secondary outcomes reported