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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 is a Early Phase 1 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02331095
The ClinicalTrials.gov registry entry for NCT02331095 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atorvastatin is the first listed.
NCT02331095 reports 0 study locations.
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.
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