Grant: Project Grant
Ottawa Hospital Research Institute
$424,298.00
Statins for Venous Event Reduction in patients with venous thromboembolism (The SAVER Pilot Randomized Trial)
FY 2015-16
Summary
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.
Department
Program
Project Grant
Recipient
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
345461
Name
Rodger Marc A
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Project Grant Competition
Projecttitle
Statins for Venous Event Reduction in patients with venous thromboembolism (The SAVER Pilot Randomized Trial)
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$424,298
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Arterial Vascular Events; Pilot Trial; Post Thrombotic Syndrome; Randomized Controlled Trial; Rosuvastatin; Statin; Treatment; Venous Thromboembolism
Abstract
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.
Competitiondate
201603
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Rodger, Marc A
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $424,298~ $0~