Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Unable or unwilling to provide written informed consent;
< 18 years of age;
Women of childbearing potential unwilling to use appropriate contraception;
Currently prescribed a statin;
Trial design
Design model
Parallel
Treatments tested in this trial
Rosuvastatin Calcium
DrugEach participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Placebo Oral Tablet
DrugEach participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Treatment groups
2,700 Participants
are divided into 2 treatment groupsGroup A: RosuvastatinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrent Major VTE
Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.
Time frame
Up to 60 monthsSecondary outcomes
1
Post Thrombotic Syndrome
Post-thrombotic syndrome as measured by the Villalta scale throughout the follow-up period in patients taking generic rosuvastatin as compared with placebo. The Villalta PTS scale has been adopted by the International Society on Thrombosis and Haemostasis (ISTH) as a standard to diagnose and grade the severity of PTS in clinical studies. Points are summed to yield total score: 0-4: No PTS; 5-9: Mild PTS; 10-14: Moderate PTS; 15 or more, or presence of ulcer: Severe PTS.
Time frame
Up to 60 months2
Number of participants diagnosed with non-major VTE during follow-up
Symptomatic non-major VTE (see below) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo. Non-major VTE: * Distal DVT (distal to the trifurcation of the popliteal vein); * Isolated sub-segmental PE; * Upper extremity DVT; * Superficial phlebitis \> 5 cm; * Superficial phlebitis ≤ 5 cm.
Time frame
Up to 60 months3
Number of participants diagnosed with an arterial vascular event during follow-up
Components of composite arterial vascular events (see below) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo. Components of composite arterial vascular events: * Fatal myocardial infarction; * Non-fatal myocardial infarction; * Hospitalization for unstable angina; * Coronary artery revascularization; * Sudden cardiac death; * Ischemic stroke.
Time frame
Up to 60 months4
Number of deaths during study participation
All-cause mortality occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.
Time frame
Up to 60 monthsOther outcomes
1
Number of participants who have a bleeding event during follow-up
Bleeding event (major, clinically relevant non-major, minor) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin as compared with placebo.
Time frame
Up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Eastern Norway Health Authorities RHF
Collaborator
Southern health region, Norway
Collaborator
Programme hospitalier de recherche clinique, France
Collaborator
British Heart Foundation
Collaborator
Source ClinicalTrials.gov