Recruiting
Phase 3

Statins

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04319627

Conditions

Venous Thromboembolism

Blood Clot

Post Thrombotic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin Calcium

Placebo Oral Tablet

Study Details

Brief summary:

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.

Conditions

Venous Thromboembolism

Blood Clot

Post Thrombotic Syndrome

Study ID

NCT04319627

Start date

Feb 10, 2021

Status verified date

Jan, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rosuvastatin

Participants randomized to the experimental arm will take one rosuvastatin 20 mg tablet by mouth every day for the duration of their participation in the study.

placebo comparator: Placebo

Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.

Interventions

Rosuvastatin Calcium

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

Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.

Primary outcome measure

  • Recurrent Major VTE [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Jennifer Brinkhurst

613-737-8899jbrinkhurst@ohri.ca

OHRI Clinical Research Quality Team

CRQuality@ohri.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Principal Investigator:

Leslie Skeith, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Sam Schulman, MD

St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Principal Investigator:

Jim Douketis, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Jennifer Brinkhurst

jbrinkhurst@ohri.ca

Principal Investigator:

Aurélien Delluc, MD

Niagara Health - St. Catharines Site

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Principal Investigator:

Blair Leonard, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Erik Yeo, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Principal Investigator:

Susan Kahn, MD

McGill Univeristy Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Principal Investigator:

Véronique Naessens, MD

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

Recruiting

Montreal, Quebec, Canada, H9R 2Y2

Principal Investigator:

Carolyne Elbaz, MD

CHU de Quebec-Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Principal Investigator:

Guillaume Roberge, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • Rosuvastatin
  • Statin
  • PTS
  • VTE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-01-15.