Clot Dissolving Treatment for Blood Clots in the Lungs

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey Kline
• Treatments: Enoxaparin; Enoxaparin sodium; Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Pulmonary vascular imaging positive for PE within the previous 24 hours

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age >17 years

• Evidence of severe PE: RV hypokinesis on echocardiography, abnormal troponin I or T (any non-normal including indeterminate values, using local reference thresholds) or BNP measurement >90 pg/mL or NT proBNP >900 pg/ml (not more than 6 hours prior to CT angiography and not more than 30 hours before enrollment) or a pulse oximetry reading <95% within previous two hours (<93% in Denver).

Exclusion Criteria:

• Systolic blood pressure < 90 mm Hg at time of informed consent

• Do not resuscitate or do not intubate order

• Systemic fibrinolytic treatment within previous 7 days

• Inability to follow-up at 3 months

• Documented gastrointestinal bleeding within previous 30 days

• Active hemorrhage in any of the following sites at the time of enrollment:

intraperitoneal, retroperitoneal, pulmonary, uterine, bladder, or nose.

• Head trauma causing loss of consciousness within previous 7 days

• Any history of hemorrhagic stroke

• Ischemic stroke within the past year

• Prior history of heparin-induced thrombocytopenia

• History of intraocular hemorrhage

• Intracranial metastasis

• Known inherited bleeding disorder, e.g., hemophilia

• Platelet count < 50,000/uL

• Prothrombin time with an INR >1.7

• Chest, abdominal, intracranial or spinal surgery within the previous 14 days

• Subacute bacterial endocarditis

• Pregnancy (positive pregnancy test)

• Prior enrollment in the study

• Current treatment with fondiparinux, dalteparin, a direct thrombin inhibitor or administration of a glycoprotein inhibitor within the previous 48 hours.

• Known pericarditis

• Allergy to heparins,or tenecteplase

• Elapsed time that would preclude drug or placebo administration within 24 hours after diagnosis

• Evidence of non-end stage kidney injury (creatinine clearance < 30 ml/min without chronic hemodialysis treatment; chronic hemodialysis-treated patients are eligible)

• Preexisting end-stage cardiopulmonary disease (heart failure with left ventricular ejection fraction <20%, known severe pulmonary hypertension or other lung disease causing permanent dependence upon oxygen)

• Any other condition that the investigator believes would pose a significant hazard to the subject