Study Stopped
PI changed institution and impossible to solve problem with contract's sites
Clot Dissolving Treatment for Blood Clots in the Lungs
Randomized Trial of Tenecteplase to Treat Severe Submassive Pulmonary Embolism
1 other identifier
interventional
83
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
August 11, 2014
CompletedOctober 12, 2022
October 1, 2022
4 years
May 16, 2008
October 29, 2013
October 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
2
PLACEBO COMPARATORSaline + Enoxaparin
1
EXPERIMENTALTenecteplase + Enoxaparin
Interventions
Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated. Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of California, Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Related Publications (2)
Zuo Z, Yue J, Dong BR, Wu T, Liu GJ, Hao Q. Thrombolytic therapy for pulmonary embolism. Cochrane Database Syst Rev. 2021 Apr 15;4(4):CD004437. doi: 10.1002/14651858.CD004437.pub6.
PMID: 33857326DERIVEDStewart LK, Peitz GW, Nordenholz KE, Courtney DM, Kabrhel C, Jones AE, Rondina MT, Diercks DB, Klinger JR, Kline JA. Contribution of fibrinolysis to the physical component summary of the SF-36 after acute submassive pulmonary embolism. J Thromb Thrombolysis. 2015 Aug;40(2):161-6. doi: 10.1007/s11239-014-1155-5.
PMID: 25433511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Kline
- Organization
- Indiana University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A Kline, MD
Carolinas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2012
Study Completion
October 1, 2012
Last Updated
October 12, 2022
Results First Posted
August 11, 2014
Record last verified: 2022-10