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NCT02331095 · ClinicalTrials.gov registry record · Early Phase 1
Statin Use in Patients With Acute VTE
A Early Phase 1 study, sponsored by Ohio State University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
NCT02331095: Clinical Trial Early Phase 1 study, sponsored by Ohio State University.
NCT02331095 is a Early Phase 1 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 21 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02331095, a Early Phase 1 study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and randomized 1:1 into "anticoagulation" arm or "anticoagulation plus atorvastatin" arm, with atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80 patients, with 40 in each arm. Patients will be recruited from the hospitals and clinics at The Ohio State University Wexner Medical Center. Follow up visits are planned at enrollment, 3 months, and 9 months after randomization. At each follow up, blood will be obtained and assessments will include structured interviews of signs and symptoms of recurrent venous thromboembolism (VTE), bleeding, post thrombotic syndrome, and adverse events from study drugs.
Primary Outcome
Determine the reduction of endogenous thrombin potential measured by Thrombin Generation Assay (TGA) at 3 months in the "anticoagulation +atorvastatin" arm as compared to the "anticoagulation" arm.
Interventions
- DRUG Atorvastatin
- DRUG Anticoagulation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-05-20 |
| Phase | Early Phase 1 |
Why NCT02331095 stopped before completion
NCT02331095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Atorvastatin is the first listed.
NCT02331095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02331095 about?
NCT02331095 is a clinical study titled "Statin Use in Patients With Acute VTE". This is a pilot, randomized, open-labelled study. Eligible patients will be enrolled and randomized 1:1 into "anticoagulation" arm or "anticoagulation plus atorvastatin" arm, with atorvastatin given at 40 mg orally daily for 3 months. The targeted total accrual is 80 patients, with 40 in each arm. P...
What is the current status of trial NCT02331095?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2015-01. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT02331095?
The interventions under investigation include: Atorvastatin (DRUG), Anticoagulation Therapy (DRUG).
Who is sponsoring clinical trial NCT02331095?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02331095's enrollment target sits among peer trials
21 1130th of 2000 higher than 844 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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