StAtins for Venous Event Reduction in Patients with Venous Thromboembolism : The SAVER Trial

Phase 1

• Conditions: Pulmonary Embolism, Deep Vein Thrombosis, Venous thromboembolism; MedDRA version: 21.0Level: LLTClassification code: 10080372Term: Leg venous thrombosis Class: 10047065; MedDRA version: 21.1Level: LLTClassification code: 10066529Term: Deep vein thrombosis recurrent Class: 10047065; MedDRA version: 20.0Level: HLTClassification code: 10037379Term: Pulmonary embolism and thrombosis Class: 10047065; MedDRA version: 20.0Level: LLTClassification code: 10014521Term: Embolism pulmonary Class: 10038738; MedDRA version: 21.1Level: LLTClassification code: 10024105Term: Left deep vein thrombosis Class: 10047065; MedDRA version: 20.0Level: PTClassification code: 10063909Term: Post procedural pulmonary embolism Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code: 10043642Term: Thrombosis venous deep Class: 10047065; MedDRA version: 21.1Level: LLTClassification code: 10049918Term: Deep venous thrombosis proximal Class: 10047065; MedDRA version: 21.1Level: LLTClassification code: 10047251Term: Venous thrombosis deep (limbs) Class: 10047065

• Registration Number: CTIS2023-504486-23-00
• Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.

Exclusion Criteria

Unable or unwilling to provide written informed consent, Patient without social security affiliation or not beneficiary of such social security (Criteria for France), < 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: a)Diabetes; b) Abdominal aortic aneurysm; c)Peripheral arterial disease; d) Stroke; e) Transient ischemic attack (TIA); f) Myocardial infarction (MI); g) Acute coronary syndromes; h) Stable/unstable angina; i) Coronary or other arterial revascularization, Known diagnosis of hypercholesterolemia or dyslipidemia, Contraindication to rosuvastatin; a) Known hypersensitivity or intolerance to statins; b) History of muscle disorders or statin-related muscle pain; c)Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver); d)Chronic kidney disease (creatinine clearance < 30ml/min); e) Currently pregnant or breast feeding; f) Taking cyclosporine; g) Taking atazanavir/ritonavir; h) Taking darolutamide; i) Taking regorafenib, Unstable medical or psychological condition that would interfere with trial participation, Life expectancy less than 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE [proximal DVT or segmental or larger PE]) in patients taking generic rosuvastatin compared to placebo;Secondary Objective: To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo., To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study., To determine if rosuvastatin reduces the incidence of arterial vascular events, To determine if rosuvastatin reduces the incidence of recurrent non-major VTE, To determine the safety of rosuvastatin;Primary end point(s): Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Post-thrombotic syndrome as measured by the Villalta score;Secondary end point(s):Non-major VTE; a) Distal DVT (distal to the trifurcation of the popliteal vein); b) Isolated sub-segmental PE; c) Upper Extremity DVT; d) Unusual site DVT; e) Superficial vein thrombosis;Secondary end point(s):Arterial vascular events: oFatal myocardial infarction oNon-fatal myocardial infarction oHospitalization for unstable angina oCoronary artery revascularization oSudden cardiac death oIschemic stroke;Secondary end point(s):All-cause mortality (no adjudication required)