Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT04319627
Phase
PHASE3
Status
Recruiting
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Conditions

  • Blood Clot
  • Post Thrombotic Syndrome
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 24, 2020
Start date
Feb 10, 2021
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
2,700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

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