Testing Rosuvastatin Calcium against a placebo for venous thromboembolism
Official title: Statins for Venous Event Reduction in Patients With Venous Thromboembolism
- Phase 3
- 2 groups
- Sites in Calgary, Halifax and 6 more cities
- Recruiting
Interventions
- Medication
Rosuvastatin Calcium
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
- Medication
Placebo Oral Tablet
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
Canadian Sites (14)
10 of 14 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Niagara Health - St. Catharines Site
St. Catharines, Ontario
- Recruiting
University Health Network
Toronto, Ontario
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
McGill Univeristy Health Centre
Montreal, Quebec
- Recruiting
CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center
Montreal, Quebec
- Recruiting
CHU de Quebec-Université Laval
Québec, Quebec
- Withdrawn
Queen Elizabeth II Hospital
Halifax, Nova Scotia
- Withdrawn
Juravinski Hospital
Hamilton, Ontario
- Withdrawn
Hôpital Montfort
Ottawa, Ontario
- Not yet recruiting
Sunnybrook Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for50 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Known hypersensitivity or intolerance to statins;
- +Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
- +\. Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Unable or unwilling to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +\< 18 years of age;
- +Currently prescribed a statin;
- +A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
- +Abdominal aortic aneurysm;
- +Peripheral arterial disease;
- +Transient ischemic attack (TIA);
- +Myocardial infarction (MI);
- +Acute coronary syndromes;
- +Stable/unstable angina;
- +Coronary or other arterial revascularization;
- +Known diagnosis of hypercholesterolemia or dyslipidemia;
- +Contraindication to rosuvastatin;
- +History of muscle disorders or statin-related muscle pain;
- +Chronic kidney disease (creatinine clearance \< 30ml/min);
- +Taking cyclosporine;
- +Taking atazanavir/ritonavir;
- +Taking darolutamide;
- +Taking regorafenib;
- +Unstable medical or psychological condition that would interfere with trial participation.
- +Women of childbearing potential unwilling to use appropriate contraception;
- +Currently pregnant or breast feeding;
Exclusion
- −Known hypersensitivity or intolerance to statins;
- −Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver);
- −Unable or unwilling to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- −\< 18 years of age;
- −Currently prescribed a statin;
- −A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
- −Abdominal aortic aneurysm;
- −Peripheral arterial disease;
- −Transient ischemic attack (TIA);
- −Myocardial infarction (MI);
- −Acute coronary syndromes;
- −Stable/unstable angina;
- −Coronary or other arterial revascularization;
- −Known diagnosis of hypercholesterolemia or dyslipidemia;
- −Contraindication to rosuvastatin;
- −History of muscle disorders or statin-related muscle pain;
- −Chronic kidney disease (creatinine clearance \< 30ml/min);
- −Taking cyclosporine;
- −Taking atazanavir/ritonavir;
- −Taking darolutamide;
- −Taking regorafenib;
- −Unstable medical or psychological condition that would interfere with trial participation.
- −Women of childbearing potential unwilling to use appropriate contraception;
- −Currently pregnant or breast feeding;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Rosuvastatin Calcium.
Registry label: A: Rosuvastatin
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo Oral Tablet.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,700 people.
The study is currently expected to finish around April 2028.
The main measurement is taken over: Up to 60 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recurrent Major VTE — measured over Up to 60 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04319627 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Rosuvastatin CalciumDrug
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo Oral TabletDrug
Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 60 months.
The study as a whole is currently expected to finish around 2028-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Calgary, Alberta, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; St. Catharines, Ontario, Canada; Toronto, Ontario, Canada, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.