At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Rosuvastatin Calcium (drug), Placebo Oral Tablet (drug)
- How long the study runs
- Study runs about 86 months (dates as stated)
- About the drug or intervention
- Rosuvastatin Calcium — drug: Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to. · Placebo Oral Tablet — drug: Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,700
- Started
- 2021-02-10
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for venous thromboembolism
- • Phase3 - 2,700 participants
- • The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with venous thromboembolism
Where?
- • Aberdeen - Aberdeen Royal Infirmary
- • Birmingham - Queen Elizabeth Hospital
- • Cardiff - University Hospital of Wales
- • Glasgow - Glasgow Royal Infirmary
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants). While treatment of blood clots with blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming. The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study. The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.
More detail
Recent research has demonstrated that it is plausible that statins have additive, and potentially even synergistic effects, in reducing recurrent VTE in patients managed with anticoagulant-based strategies. Furthermore, it is plausible that statins may reduce the risk of recurrent VTE in those not on anticoagulants and therefore offer an alternative in patients with contraindications to anticoagulants (e.g. after major intracranial bleed), who refuse to take anticoagulants long-term (e.g. due to lifestyle modifications or fear of bleeding) or who cannot afford anticoagulants (e.g. vulnerable or impoverished populations). Finally, statins may also provide protection from recurrent VTE in patients who are not fully compliant with anticoagulant therapy. However, no known RCTs have been done to explore these possibilities. This study aims to determine if generic rosuvastatin reduces the risk of recurrent VTE compared to placebo in patients with symptomatic major VTE. Primary Objectives \- To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE \[proximal DVT or segmental or larger PE\]) in patients taking generic rosuvastatin compared to placebo. Secondary Objectives * To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo. * To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓1\. causing symptoms objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE...
- ✓Exclusion criteria
- ✓Unable or unwilling to provide written agreement to take part;
- ✓\< 18 years of age;
- ✓Women of childbearing potential unwilling to use appropriate contraception;
See the full criteria
Where Is This Study? (6 UK sites)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
How to Get in Touch
Jennifer Brinkhurst
Sponsor contactCONTACT
OHRI Clinical Research Quality Team
Sponsor contactCONTACT