Statins for Venous Event Reduction in Patients With Venous Thromboembolism (NCT04319627)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (27 items).
Location: Foothills Medical Centre — Calgary, Alberta
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria
- 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;
- A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention:
- Diabetes;
- Abdominal aortic aneurysm;
- Peripheral arterial disease;
- Stroke;
- Transient ischemic attack (TIA);
- Myocardial infarction (MI);
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (31 Sites)
- Foothills Medical Centre — Calgary, Alberta
- Queen Elizabeth II Hospital — Halifax, Nova Scotia
- Hamilton General Hospital — Hamilton, Ontario
- St. Joseph's Healthcare — Hamilton, Ontario
- Juravinski Hospital — Hamilton, Ontario
- The Ottawa Hospital — Ottawa, Ontario
- Hôpital Montfort — Ottawa, Ontario
- Niagara Health - St. Catharines Site — St. Catharines, Ontario
- Sunnybrook Hospital — Toronto, Ontario
- University Health Network — Toronto, Ontario
- Jewish General Hospital — Montreal, Quebec
- McGill Univeristy Health Centre — Montreal, Quebec
- CIUSSS de-l'Ouest-de-l'Ile-de-Montreal -St. Mary's Hospital Center — Montreal, Quebec
- CHU de Quebec-Université Laval — Québec, Quebec
- CHU d'Angers - Service d'accueil et traitement des Urgences — Angers,
- Brest University Hospital Centre — Brest,
- CHU de Clermont-Ferrand, Hôpital Gabriel Montpied — Clermont-Ferrand,
- APHP Hôpital Louis Mourier — Colombes,
- CHU de Dijon - Service d'imagerie diagnostique et thérapeutique — Dijon,
- GH La Rochelle - Ré-Aunis - Service de Médecine vasculaire — La Rochelle,
- Centre Hospitalier Universitaire De Saint Etienne — Saint-Etienne,
- CHI Toulon - La Seyne sur Mer - Hôpital Sainte Musse — Toulon,
- Mater Misericordiae University Hospital — Dublin,
- University of Insubria — Varese,
- Ostfold Hopsital — Sarpsborg,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.