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Rosuvastatin for Deep Vein Thrombosis
Phase 1 & 2
Recruiting
Led By Khanh P Nguyen, MD
Research Sponsored by Khanh Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have ECOG performance status ≤ 2
Diagnosis of a first episode of acute proximal leg DVT within 4 weeks of initial DVT diagnosis and without symptomatic pulmonary embolism (PE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 day
Awards & highlights
Study Summary
This trial is testing whether adding rosuvastatin to standard anticoagulation therapy is safe and effective in preventing PTS after DVT.
Who is the study for?
This trial is for men and women with a first episode of acute proximal leg DVT diagnosed within the last 4 weeks, without severe pulmonary embolism. Participants must be in relatively good health (ECOG ≤ 2), have a life expectancy over 2 years, and meet specific blood count criteria. Exclusions include pregnancy, breastfeeding, prisoners, those already in another trial or with established PTS, certain allergies or contraindications to MRI or anticoagulants.Check my eligibility
What is being tested?
The study tests if rosuvastatin (20 mg daily) alongside standard anticoagulation therapy can improve safety and tolerability while preventing post thrombotic syndrome after a DVT event. The effectiveness of this combination treatment will be compared against the usual care for patients with lower extremity DVT.See study design
What are the potential side effects?
Rosuvastatin may cause muscle pain or weakness, liver enzyme changes leading to potential liver damage, digestive issues like nausea or constipation, headache, dizziness and increased risk of diabetes. Side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
I was diagnosed with a blood clot in my leg for the first time within the last 4 weeks and do not have lung complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-thrombotic syndrome
Secondary outcome measures
Severity of post-thrombotic syndrome (PTS)
Side effects data
From 2018 Phase 4 trial • 12 Patients • NCT030746308%
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100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: RosuvastatinExperimental Treatment1 Intervention
Subjects will receive 20 mg daily dose of rosuvastatin for at least 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
FDA approved
Find a Location
Who is running the clinical trial?
Khanh NguyenLead Sponsor
Khanh P Nguyen, MDPrincipal InvestigatorPortland VA Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Before starting blood thinning medication, your blood clotting tests must show normal results: INR should be 1.5 or less, and aPTT should be 40 or less.I have not had any active cancer in the past year.You are expected to live for more than 2 years.My limb's blood flow is severely reduced, risking its survival.You cannot have an MRI scan because you have metal implants or feel very scared in small, enclosed spaces.I had a deep vein thrombosis (DVT) within the last 2 years.You need to have enough platelets in your blood before starting anticoagulation: Platelet count should be more than 100 billion per liter.I have a history of unusual bleeding.I am either a man or a woman.Before starting blood thinners, you need to have enough hemoglobin: more than 9 mg/dL.Your hemoglobin level is less than 9 mg/dL, indicating anemia.I have had a severe lung clot affecting my heart's function.I am not taking any strong medication that affects how drugs are processed in my body.I have had serious bleeding problems, including in my stomach or brain.I am able to get out of my bed or chair and move around.Your blood platelet count is less than 100,000 per milliliter.I have had more than one deep vein thrombosis.I was diagnosed with a blood clot in my leg for the first time within the last 4 weeks and do not have lung complications.I am allergic to or cannot take blood thinners or specific medications.I have been diagnosed with post-thrombotic syndrome.My kidney function is severely impaired.I do not need urgent surgery that can't wait 3 months.Your blood clotting test results are abnormal before starting treatment.My liver function is severely impaired.I have not had any active bleeding in the last 3 months.I have a history of chronic atrial fibrillation or stroke.You are not expected to live more than 2 years.You have had a bad reaction to the drug or its ingredients in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Rosuvastatin
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the requirements for this trial compatible with my situation?
"In order to be considered for this trial, applicants must present with thrombus and span the age gap of 18-85. This clinical investigation is accepting a total of 30 participants."
Answered by AI
Are there currently any opportunities to participate in this experiment?
"Affirmative. Data hosted on clinicaltrials.gov underscores that this investigation, which was first disclosed on June 1st 2021, is actively recruiting potential candidates. Approximately 30 individuals will be recruited from one site."
Answered by AI
What medical conditions commonly respond to Rosuvastatin treatment?
"Rosuvastatin is a common remedy for hypertriglyceridemias. Additionally, it has been used to combat cardiovascular disease (CVD), cardiac-related events, and postoperative recovery from cardiovascular surgeries."
Answered by AI
What is the current capacity of this research study in regards to participants?
"Affirmative. Clinicaltrials.gov showcases that this clinical trial, which was initially advertised on June 1st 2021, is actively seeking participants. A total of 30 medical subjects are being recruited from a single site."
Answered by AI
Are participants aged 50 or over being recruited for this assessment?
"Patient eligibility for this trial requires an age range of 18 to 85 years old. For participants younger than 18, there are 13 clinical trials available and 191 studies for individuals aged 65 or over."
Answered by AI
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