Statins for Blood Clots
(SAVER Trial)
Recruiting in Palo Alto (17 mi)
+17 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must be taking:Anticoagulants
Must not be taking: Statins, Cyclosporine, Atazanavir
Disqualifiers: Diabetes, Stroke, Liver disease, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking a statin or certain other medications like cyclosporine or atazanavir/ritonavir.
What data supports the effectiveness of the drug Rosuvastatin (Crestor) for preventing blood clots?
Rosuvastatin (Crestor) has been shown to reduce the risk of major cardiovascular events, including venous thromboembolism (a type of blood clot), in patients with elevated hsCRP levels, as demonstrated in the JUPITER trial.
12345Is rosuvastatin (Crestor) generally safe for humans?
Rosuvastatin (Crestor) is generally well tolerated and has a safety profile similar to other statins, meaning it is considered safe for use in humans when used as directed.
26789How does the drug rosuvastatin differ from other treatments for blood clots?
Rosuvastatin is unique because it not only lowers cholesterol but also has anti-inflammatory effects, which may help in preventing blood clots. Unlike other statins, it is highly potent and selective for liver cells, reducing the risk of interactions with other drugs.
128910Eligibility Criteria
This trial is for adults who've had a recent deep vein thrombosis or pulmonary embolism. It's not for those with liver disease, severe kidney issues, on certain medications like cyclosporine, pregnant/breastfeeding women, under 18s, or anyone already taking statins. Participants must be willing to use contraception if of childbearing potential.Exclusion Criteria
I have a known liver disease.
I cannot take rosuvastatin due to health reasons.
I am currently taking atazanavir/ritonavir.
I am a woman who can have children and do not want to use birth control.
I am currently taking regorafenib.
I am 18 years old or younger.
I have had muscle disorders or pain from cholesterol medication.
I am currently taking darolutamide.
I am currently taking a statin medication.
I am currently taking cyclosporine.
I have a condition like heart disease or diabetes that requires statins.
My kidneys are not working well (low creatinine clearance).
Participant Groups
The study tests whether adding rosuvastatin (a cholesterol-lowering drug) to standard blood thinner treatment can prevent new blood clots and reduce vein damage in patients with blood clots. Some participants will receive rosuvastatin while others get a placebo tablet that has no active ingredients.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RosuvastatinExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sunnybrook HospitalToronto, Canada
University Health NetworkToronto, Canada
St. Joseph's HealthcareHamilton, Canada
CHU de Quebec-Université LavalQuebec City, Canada
More Trial Locations
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. [2019]Rosuvastatin (Crestor), a new, highly efficacious statin, has demonstrated dose-dependent low-density lipoprotein cholesterol (LDL-C) reductions of up to 65% in a dose-ranging programme with doses of 1 to 80 mg.
Rosuvastatin: a review of its use in the prevention of cardiovascular disease in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels. [2015]Rosuvastatin (Crestor®) is an HMG-CoA reductase inhibitor (statin) that has both lipid-lowering and anti-inflammatory effects. The drug has various indications in the US, including the primary prevention of cardiovascular disease (CVD) in patients with no clinical evidence of coronary heart disease who are at increased risk of CVD based on their age, a high-sensitivity C-reactive protein (hsCRP) level of ≥2 mg/L, and at least one other CVD risk factor. The efficacy of rosuvastatin in apparently healthy women (aged ≥60 years) or men (aged ≥50 years) with normal low-density lipoprotein cholesterol (LDL-C) levels and elevated hsCRP levels was demonstrated in the large, randomized, double-blind, multinational, JUPITER trial. Relative to placebo, rosuvastatin 20 mg once daily for a median follow-up of 1.9 years significantly reduced the occurrence of first major cardiovascular events in this trial (primary endpoint). A between-group difference in favor of rosuvastatin was also demonstrated for various other endpoints, including overall deaths and the nonatherothrombotic endpoint of venous thromboembolism. Rosuvastatin remained more effective than placebo when primary endpoint results were stratified according to various baseline factors, including in patient subgroups thought to be at low risk of CVD. In addition, rosuvastatin was associated with reductions in LDL-C and hsCRP levels, and these reductions appeared to occur independently of each other. The greatest clinical benefit was observed in rosuvastatin recipients achieving an LDL-C level of
Rosuvastatin: a review of its use in the management of dyslipidemia. [2018]Rosuvastatin (Crestor), an HMG-CoA reductase inhibitor (statin), has a favorable pharmacologic profile, including its selective uptake by hepatic cells, hydrophilic nature, and lack of metabolism by cytochrome p450 (CYP) 3A4 isoenzyme. This last property means that the potential for CYP3A4-mediated drug interactions and, as a consequence, adverse events is low in those requiring concomitant therapy with a statin and agents metabolized by CYP3A4. In a broad spectrum of adult patients with dyslipidemias, oral rosuvastatin 5-40 mg once daily effectively and rapidly improved lipid profiles in several large, randomized, mainly double-blind, multicenter trials of up to 52 weeks' duration. After 12 weeks' treatment, rosuvastatin was significantly (all p
Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia. [2019]This randomized, double-blind, placebo-controlled trial was conducted in 52 centers in North America to compare the effects of the new, highly effective statin, rosuvastatin, with atorvastatin and placebo in hypercholesterolemic patients. After a 6-week dietary run-in, 516 patients with low-density lipoprotein (LDL) cholesterol > or =4.14 mmol/L (160 mg/dl) and
Clinical experience with rosuvastatin in the management of hyperlipidemia and the reduction of cardiovascular risk. [2015]On the basis of large randomized clinical trials, pharmacological antagonists of HMG-CoA reductase (statins) have become increasingly used in clinical practice for the prevention of cardiovascular disease. Rosuvastatin was developed as a potent statin, which appeared to raise levels of HDL-cholesterol, in addition to marked reductions in levels of LDL-cholesterol. These effects on lipids are associated with a beneficial impact of rosuvastatin on progression of various stages of atherosclerosis and cardiovascular outcomes in clinical trials. The clinical experience of rosuvastatin will be reviewed in this article.
Rosuvastatin: a high-potency HMG-CoA reductase inhibitor. [2019]To summarize the relevant pharmacologic, clinical, and safety data regarding rosuvastatin (Crestor--AstraZeneca), the most recently marketed 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor approved for the treatment of dyslipidemia.
Rosuvastatin: do we need another statin? [2010](1) Rosuvastatin (Crestor(TM)) is a new synthetic agent for the treatment and prevention of lipid disorders, a risk factor for coronary heart disease. (2) Rosuvastatin is undergoing phase III clinical trials. A New Drug Application was submitted to the U.S. Food and Drug Administration in June, 2001. No information on the regulatory status in Canada is currently available. (3) Limited evidence from small clinical trials suggests that rosuvastatin may produce larger dose-dependent decreases in total cholesterol levels and low-density lipoprotein-cholesterol levels in hypercholesterolemic patients compared to other statins. There is insufficient evidence to draw conclusions about the safety of rosuvastatin. (4) The impact of rosuvastatin therapy on cardiac morbidity and mortality is not known. More experience is required to determine the effectiveness and relative benefits of this new drug.
Optimizing the pharmacology of statins: characteristics of rosuvastatin. [2019]Rosuvastatin (Crestor, AstraZeneca) is a new synthetic statin that exhibits a number of highly desirable pharmacologic characteristics. The drug has a high affinity for the active site of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase and exhibits greater potency in inhibiting enzyme activity and cholesterol synthesis in vitro than other statins. The effects of rosuvastatin are selective for hepatic cells, and there is minimal uptake of the drug by nonhepatic tissues. The vast majority of biologic activity of the drug is associated with the parent compound, which does not appear to undergo extensive metabolism. Hepatic metabolism appears to be minimal, and there is little evidence of metabolic interaction with cytochrome P450 3A4. In an early-phase study, rosuvastatin produced large and dose-related decreases in low-density lipoprotein (LDL) cholesterol of up to 65% in hypercholesterolemic patients. Rosuvastatin should constitute an important addition to current lipid-lowering interventions.
Rosuvastatin--a highly effective new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor: review of clinical trial data at 10-40 mg doses in dyslipidemic patients. [2017]Rosuvastatin (Crestor; licensed to AstraZeneca, Macclesfield, UK from Shionogi, Osaka, Japan) is a new statin with pharmacologic characteristics that translate into selectivity of effect in hepatic cells and enhanced potency in 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibition. It is approved for use at doses of 10-40 mg once daily to reduce low-density lipoprotein (LDL) cholesterol, increase high-density lipoprotein (HDL) cholesterol and improve other lipid measures in dyslipidemic patients. In a dose-ranging study in mild/moderate hypercholesterolemia, rosuvastatin reduced LDL cholesterol by 52-63% at 10-40 mg. Rosuvastatin 10 mg reduces LDL cholesterol significantly more than atorvastatin 10 mg, simvastatin 10-40 mg and pravastatin 10-40 mg, and enables significantly more patients to achieve National Cholesterol Education Program and Joint European Societies LDL cholesterol goals compared with each of these statins. Rosuvastatin also produces marked elevations in HDL cholesterol and maintains this effect across the dose range. Rosuvastatin favorably modifies triglycerides, LDL cholesterol and other lipid measures in patients with hypertriglyceridemia or mixed dyslipidemia, including diabetic patients, and may constitute a monotherapy option for many such patients. Rosuvastatin is well tolerated when used alone or in combination, exhibiting a safety profile similar to that of other available statins. Rosuvastatin offers considerable advantages for use in routine clinical practice.
Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. [2022]Rosuvastatin is a new, synthetic, orally active statin, with marked low-density lipoprotein (LDL) cholesterol-lowering activity. We conducted 2 dose-ranging studies. In the first study, after a 6-week dietary run-in, 142 moderately hypercholesterolemic patients were randomized equally to receive double-blind placebo or rosuvastatin 1, 2.5, 5, 10, 20, or 40 mg or open-label atorvastatin 10 or 80 mg once daily for 6 weeks; in the second study, conducted to extend the rosuvastatin dose range, 64 patients were randomized to double-blind, once-daily placebo or rosuvastatin 40 or 80 mg (1:1:2 ratio) for 6 weeks. Data from both studies were combined for analysis of lipid effects. No statistical comparison of atorvastatin arms with placebo or rosuvastatin was performed. Rosuvastatin was associated with highly significant dose-dependent reductions in LDL cholesterol compared with placebo (p