Statins for Venous Event Reduction in patients with venous thromboembolism (The SAVER Pilot Randomized Trial)

Venous thromboembolism is the medical term used for blood clots in the veins. Blood clots in the veins of the legs are called deep vein thrombosis (DVT) and blood clots in the lungs are called pulmonary embolism (PE). These blood clots are common and affect more than 50,000 Canadians every year. Many individuals who have a blood clot are at increased risk of having another blood clot in the future. They are commonly prescribed medication to prevent a future blood clot. Rosuvastatin is a medication that belongs to a family of drugs called statins. They are prescribed for patients with elevated cholesterol levels and have been found to decrease events such as heart attack and stroke. It is possible that statins may also be useful for the prevention of blood clots in the veins and for prevention of complications in the legs following a blood clot. However, little research has been done to investigate this potential. We plan to conduct a large international study with over 3000 patients at 34 hospitals. The objective of the study is to test if rosuvastatin is effective and safe for preventing future blood clots. This application is for a smaller study called a pilot study. The objective is to prove that the large study can be completed. Another objective of our pilot study is to see if rosuvastatin reduces painful complications in the legs following a blood clot. We plan to include 312 people from 4 Canadian hospitals in the pilot study. All participants will have had a blood clot in their leg or their lungs. They will be randomized (like flipping a coin) to either the treatment group or the control group. The treatment group will receive one tablet of Rosuvastatin every day for 6 months. The control group will receive one placebo tablet (sugar pill) every day for 6 months. All participants will be followed for 6 months to check for side effects of the medication, new blood clots, and leg complications after a blood clot.