Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis (START)
This study is currently recruiting participants.
Verified December 2012 by Leiden University Medical Center
Sponsor:
Leiden University Medical Center
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
Willem M. Lijfering, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01613794
First received: May 31, 2012
Last updated: December 12, 2012
Last verified: December 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 31, 2012 | ||||||||
| Last Updated Date | December 12, 2012 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Coagulation factor VIII [ Time Frame: 28 days ] [ Designated as safety issue: No ] Change in factor VIII level from baseline to 28 days of intervention |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01613794 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis | ||||||||
| Official Title ICMJE | Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis | ||||||||
| Brief Summary | Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial cardiovascular disease after venous thrombosis, most predominant in the first year following initial venous thrombosis. The results of recent observational studies that showed 40-50% risk reductions for first venous thrombosis occurrence when using a statin are in this aspect promising. The results are also somewhat surprising, because the mechanism behind this effect is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that statins decrease venous thrombosis risk by lipid lowering activities. Recent observations indicate that coagulation can activate the initial formation of atherosclerosis. Our hypothesis is therefore that the coagulation profile in persons with venous thrombosis is improved when using a statin, ultimately leading to less atherosclerosis: another well known property of statin use. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Rosuvastatin
20 mg od
Other Name: crestor |
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| Study Arm (s) |
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| Publications * | Lijfering WM, Flinterman LE, Vandenbroucke JP, Rosendaal FR, Cannegieter SC. Relationship between venous and arterial thrombosis: a review of the literature from a causal perspective. Semin Thromb Hemost. 2011 Nov;37(8):885-96. Epub 2011 Dec 23. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01613794 | ||||||||
| Other Study ID Numbers ICMJE | 2011T012, 2012-000223-41 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Willem M. Lijfering, Leiden University Medical Center | ||||||||
| Study Sponsor ICMJE | Leiden University Medical Center | ||||||||
| Collaborators ICMJE | Netherlands Heart Foundation | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Leiden University Medical Center | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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