Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis (START)
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional basic science trial for Deep Vein Thrombosis focused on measuring Deep vein thrombosis, Pulmonary embolism, Rosuvastatin treatment, Pharmacologic actions
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using < 1 month anticoagulant treatment as indicated by their treating physician
- Persons aged 18 years or above
Exclusion Criteria:
- Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
- History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
- Life expectancy less than 6 months
- Pregnant woman or woman with childbearing potential who are not willing to use contraception
- Active liver or kidney disease or dysfunction or muscle disorders
- Unstable medical or psychological condition that interferes with study participation
Sites / Locations
- Trombosedienst Medial
- Leiden anticoagulation clinic
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Rosuvastatin
Arm Description
Outcomes
Primary Outcome Measures
Coagulation factor VIII
Change in factor VIII level from baseline to 28 days of intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01613794
First Posted
May 31, 2012
Last Updated
January 13, 2017
Sponsor
Leiden University Medical Center
Collaborators
Netherlands Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01613794
Brief Title
Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis
Acronym
START
Official Title
Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Netherlands Heart Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism
Keywords
Deep vein thrombosis, Pulmonary embolism, Rosuvastatin treatment, Pharmacologic actions
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Title
Rosuvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
crestor
Intervention Description
20 mg od
Primary Outcome Measure Information:
Title
Coagulation factor VIII
Description
Change in factor VIII level from baseline to 28 days of intervention
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using < 1 month anticoagulant treatment as indicated by their treating physician
Persons aged 18 years or above
Exclusion Criteria:
Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
Life expectancy less than 6 months
Pregnant woman or woman with childbearing potential who are not willing to use contraception
Active liver or kidney disease or dysfunction or muscle disorders
Unstable medical or psychological condition that interferes with study participation
Facility Information:
Facility Name
Trombosedienst Medial
City
Hoofddorp
State/Province
Zuid Holland
ZIP/Postal Code
2134TM
Country
Netherlands
Facility Name
Leiden anticoagulation clinic
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2300RC
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22198853
Citation
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. doi: 10.1055/s-0031-1297367. Epub 2011 Dec 23.
Results Reference
background
PubMed Identifier
34953155
Citation
Ramberg C, Hindberg K, Biedermann JS, Cannegieter SC, van der Meer FJ, Snir O, Leebeek FWG, Kruip MJHA, Hansen JB, Lijfering WM. Rosuvastatin treatment decreases plasma procoagulant phospholipid activity after a VTE: A randomized controlled trial. J Thromb Haemost. 2022 Apr;20(4):877-887. doi: 10.1111/jth.15626. Epub 2022 Jan 8.
Results Reference
derived
PubMed Identifier
27094802
Citation
Biedermann JS, Cannegieter SC, Roest M, van der Meer FJ, Reitsma PH, Kruip MJ, Lijfering WM. Platelet reactivity in patients with venous thrombosis who use rosuvastatin: a randomized controlled clinical trial. J Thromb Haemost. 2016 Jul;14(7):1404-9. doi: 10.1111/jth.13343. Epub 2016 Jun 10.
Results Reference
derived
PubMed Identifier
23629822
Citation
Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29.
Results Reference
derived
Learn more about this trial
Rosuvastatin Use to Improve the Coagulation Profile in Patients With Venous Thrombosis
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