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Randomized Trial of Tenecteplase to Treat Severe Submassive Pulmonary Embolism
The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and effective in the treatment of patients with severe submassive pulmonary embolism.
Details
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 83 |
| Start date | 2008-05 |
| Completion | 2012-10 |
Conditions
- Pulmonary Embolism
Interventions
- Tenecteplase + Enoxaparin
- 0.9% Saline + Enoxaparin
Primary outcomes
- Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage — 1,2,3,4, and 5 days
- Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36) — 90 days
- Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome — 90 days
Countries
United States