Study Stopped
COVID-19 pandemic and high proportion of patients meeting exclusion criteria.
STAT-STatin and Aspirin in Trauma
STAT
STAT (STatins and Aspirin in Trauma) Trial: A Phase II, Pragmatic, Prospective, Randomized, Double-blind, Adaptive Clinical Trial Examining the Efficacy of Statins and Aspirin in the Reduction of Acute Lung Injury and Venous Thromboembolism in Patients With Fibrinolysis Shutdown
1 other identifier
interventional
43
1 country
1
Brief Summary
This is a phase II, pragmatic, prospective, randomized, double-blind, adaptive clinical trial examining the efficacy of statins and aspirin in the reduction of acute lung injury and venous thromboembolism in patients with fibrinolysis shutdown.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
Typical duration for phase_2
1 active site
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
First Submitted
Initial submission to the registry
January 24, 2016
CompletedFirst Posted
Study publicly available on registry
September 15, 2016
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedResults Posted
Study results publicly available
April 27, 2023
CompletedApril 27, 2023
April 1, 2023
4.3 years
January 24, 2016
May 20, 2022
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of VTE
Based on screening duplex ultrasound (US) of legs and central line on day 5 or upon ICU discharge or upon symptoms of VTE (whichever comes first).
Day 5 or ICU discharge or upon symptoms of VTE (whichever comes first)
Secondary Outcomes (8)
Fibrinolysis Phenotypes
During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hours
Plasminogen Activator Inhibitor (PAI) - 1 and Tissue Plasminogen Activator (tPA) Levels in Plasma
During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hours
Incidence of Acute Lung Injury (ALI)
Within two weeks post-injury
Ventilator Free Days
Up to 28 days
Incidence of Arterial Thrombotic Complications: Myocardial Infarction (MI) and Cerebrovascular Accident (CVA).
Up to 28 days
- +3 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALAdministration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Control
PLACEBO COMPARATORAdministration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Interventions
Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
Eligibility Criteria
You may not qualify if:
- Known inherited bleeding disorder or coagulopathy
- Known contraindication to pharmacologic anticoagulation
- Spinal column fracture with epidural hematoma
- Head trauma/central nervous system injury
- Severe TBI; defined as AIS Head \>3
- Intracranial hemorrhage; subdural or epidural hematoma
- Neurosurgery service objection; neurosurgical contra-indications will be documented
- Ongoing hemorrhage requiring blood product transfusion
- Thrombocytopenia (platelet count \< 50,000)
- Non-operatively managed liver or spleen injuries Grade III or above
- Known chronic kidney disease (GFR \< 15ml/min)
- Rising creatinine (Cr \> 1.5x baseline) at the time of enrollment
- Documented previous ischemic strokes
- Receiving statin or aspirin therapy pre-injury, as potentially being assigned for Control would increase patient's risks
- Known allergy or other contraindication to statins or aspirin
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health Medical Center
Denver, Colorado, 80204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Coordinator, James Chandler
- Organization
- Denver Health Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest E Moore, MD
Denver Health Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
January 24, 2016
First Posted
September 15, 2016
Study Start
February 3, 2017
Primary Completion
May 24, 2021
Study Completion
August 1, 2021
Last Updated
April 27, 2023
Results First Posted
April 27, 2023
Record last verified: 2023-04