Statins for reduction of recurrent venous thrombosis

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-001559-15-NO
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-30
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2700

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

1. Unable or unwilling to provide written informed consent;
2. = 18 years of age;
3. Women of childbearing potential1 unwilling to use appropriate contraception2;
4. Currently prescribed a statin;
5. A known medical history or current diagnosis of any of the following:
? Diabetes;
? Abdominal aortic aneurysm;
? Peripheral arterial disease presumed to be of atherosclerotic origin;
? Stroke;
? Transient ischemic attack (TIA);
? Myocardial infarction (MI);
? Acute coronary syndromes;
? Stable/unstable angina;
? Coronary or other arterial revascularization.
6. Known diagnosis of hypercholesterolemia or dyslipidemia;
7. Contraindication to rosuvastatin;
? Known hypersensitivity or intolerance to statins;
? History of muscle disorders or statin-related muscle pain;
? Known liver disease (active liver disease or unexplained elevations of serum transaminases exceeding 3 times the upper limit of normal);
? Chronic kidney disease (Creatinine clearance < 30ml/min within previous 3 months);
? Currently pregnant or breast-feeding;
? Taking cyclosporine;
? Taking atazanavir/ritonavir.
8. Unstable medical or psychological condition that would interfere with trial participation

Study & Design

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