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NCT01524653 · ClinicalTrials.gov registry record · Phase 2
Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)
A Phase 2 study of Neoplasms and Venous Thromboembolism, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01524653 is a Phase 2 study of Neoplasms and Venous Thromboembolism that has completed, run by University of Vermont. The registered enrollment target is 38 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01524653, a Phase 2 study of Neoplasms and Venous Thromboembolism, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with cancer have a high risk of developing venous blood clots or thromboembolism (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis (protective treatment for blood clots), numerous studies have identified serum biomarkers for risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of statin therapy on the risk of developing VTE in high-risk populations including patients with advanced cancer. The purpose of this research study is to find out whether treatment with rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and tolerance of rosuvastatin therapy in this population. This is a phase II randomized crossover study with two 3-4 week treatment periods during which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a matching placebo tablet. Approximately two tablespoons of blood will be collected for biomarker analysis at the beginning and end of each treatment period. After the first treatment period there will be a 3-5 week break where subjects will undergo a washout. Following this washout period every subject will "crossover" or begin taking the alternative therapy so everyone enrolled will receive the study drug either during the first or the second treatment period. Biomarker levels will be analyzed in both treatment periods and compared to baseline, with every patient acting as their own control.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rosuvastatin
Study Locations (1)
Vermont
- Fletcher Allen Health Care - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01524653
The ClinicalTrials.gov registry entry for NCT01524653 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01524653 reports 1 study location spanning 1 distinct geographic area - top geographies include Vermont.
Frequently Asked Questions
What is clinical trial NCT01524653 about?
NCT01524653 is a clinical study titled "Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)". Patients with cancer have a high risk of developing venous blood clots or thromboembolism (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis (protective treatment for blood clots), numerous studies have identified serum biomarkers for risk of future VTE. There is al...
What is the current status of trial NCT01524653?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2012-03. Estimated completion is 2016-09-01.
What conditions does trial NCT01524653 study?
This clinical trial studies the following conditions: Neoplasms, Venous Thromboembolism, Deep Vein Thrombosis.
What interventions are being tested in trial NCT01524653?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT01524653?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01524653 being conducted?
This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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