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Could a cholesterol drug stop blood clots from coming back?

NCT ID NCT04319627

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether adding rosuvastatin (a common cholesterol-lowering drug) to standard blood thinner treatment can lower the risk of another blood clot in people who have recently had a deep vein thrombosis or pulmonary embolism. About 2,700 participants will receive either rosuvastatin or a placebo pill alongside their usual care. The goal is to see if the statin reduces recurrent clots and helps prevent long-term vein damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rosuvastatin (a cholesterol-lowering statin drug)
What this could lead to
If it works, this could show that adding a common statin to standard blood thinners helps prevent future blood clots and reduces long-term vein damage.
What could go wrong
This is a large phase 3 trial, but statins are not yet proven for this use. The benefit may be small or absent, and statins can cause muscle pain or rare liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. 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 criteria 1. Unable or unwilling to provide written informed consent; 2. \< 18 years of age; 3. Women of childbearing potential unwilling to use appropriate contraception; 4. Currently prescribed a statin; 5. A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention: 1. Diabetes; 2. Abdominal aortic aneurysm; 3. Peripheral arterial disease; 4. Stroke; 5. Transient ischemic attack (TIA); 6. Myocardial infarction (MI); 7. Acute coronary syndromes; 8. Stable/unstable angina; 9. Coronary or other arterial revascularization; 6. Known diagnosis of hypercholesterolemia or dyslipidemia; 7. Contraindication to rosuvastatin; 1. Known hypersensitivity or intolerance to statins; 2. History of muscle disorders or statin-related muscle pain; 3. Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver); 4. Chronic kidney disease (creatinine clearance \< 30ml/min); 5. Currently pregnant or breast feeding; 6. Taking cyclosporine; 7. Taking atazanavir/ritonavir; 8. Taking darolutamide; 9. Taking regorafenib; 8. Unstable medical or psychological condition that would interfere with trial participation.

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Conditions

The condition(s) this trial relates to.

post-thrombotic syndrome Postthrombotic Syndrome pulmonary embolism thrombotic disease venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood clot Post-thrombotic syndrome Venous thromboembolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Hôpital Louis Mourier

    RECRUITING

    Colombes, France

  • Aberdeen Royal Infirmary

    NOT_YET_RECRUITING

    Aberdeen, United Kingdom

  • Brest University Hospital Centre

    RECRUITING

    Brest, France

  • CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse

    RECRUITING

    Toulon, France

  • CHU d'Angers - Service d'accueil et traitement des Urgences

    RECRUITING

    Angers, France

  • CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, France

  • CHU de Dijon - Service d'imagerie diagnostique et thérapeutique

    RECRUITING

    Dijon, France

  • CHU de Quebec-Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G2, Canada

  • CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center

    RECRUITING

    Montreal, Quebec, H9R 2Y2, Canada

  • Centre Hospitalier Universitaire De Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire

    RECRUITING

    La Rochelle, France

  • Glasgow Royal Infirmary

    NOT_YET_RECRUITING

    Glasgow, United Kingdom

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hôpital Montfort

    WITHDRAWN

    Ottawa, Ontario, K1K 0T2, Canada

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Hospital

    WITHDRAWN

    Hamilton, Ontario, L8V 1C3, Canada

  • King's College Hospital NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • Mater Misericordiae University Hospital

    NOT_YET_RECRUITING

    Dublin, Ireland

  • McGill Univeristy Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Niagara Health - St. Catharines Site

    RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

  • Ostfold Hopsital

    RECRUITING

    Sarpsborg, Norway

  • Oxford University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Queen Elizabeth Hospital

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Queen Elizabeth II Hospital

    WITHDRAWN

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • St. Joseph's Healthcare

    RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • Sunnybrook Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Hospital of Wales

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • University of Insubria

    NOT_YET_RECRUITING

    Varese, Italy

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