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Due to discussion regarding the design of the study.
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This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral Treatment |
|
| 2 | Placebo Comparator | Oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin (AZD4522) | Drug | Oral dose (od) 20 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE)) | Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months | |
| Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE) | Time to first occurrence in the overall treatment period and during the "on (VKA)" treatment period, with an estimated average "on (VKA) treatment period" of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. R. Büller, MD, PhD | Academic Medical Centre | Principal Investigator |
| Michael Cressman, MD | AstraZeneca | Study Director |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo | Drug | Oral dose (od) |
|
| Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |