Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

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