Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03309618 |
Date of registration:
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04/10/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan
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Scientific title:
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Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study |
Date of first enrolment:
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November 2012 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03309618 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- history of MI in the last 0.5 to 5 years
- males
- aged under 55 years
Exclusion Criteria:
- diabetes mellitus
- manifest peripheral artery disease or carotid artery disease
- acute infection
- chronic diseases
- present therapy with fluvastatin and/or valsartan.
Age minimum:
N/A
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Intervention(s)
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Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
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Drug: placebo
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Primary Outcome(s)
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brachial flow mediated dilatation (FMD)
[Time Frame: 30 days]
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carotid pulse wave velocity (c-PWV)
[Time Frame: 30 days]
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carotid-femoral pulse wave velocity (cf-PWV)
[Time Frame: 30 days]
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ß-stiffness coefficient
[Time Frame: 30 days]
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reactive hyperemia index (RHI)
[Time Frame: 30 days]
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Secondary Outcome(s)
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carotid-femoral pulse wave velocity (cf-PWV)
[Time Frame: 10 weeks after termination of intervention]
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brachial flow mediated dilatation (FMD)
[Time Frame: 10 weeks after termination of intervention]
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carotid pulse wave velocity (c-PWV)
[Time Frame: 10 weeks after termination of intervention]
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reactive hyperemia index (RHI)
[Time Frame: 10 weeks after termination of intervention]
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ß-stiffness coefficient
[Time Frame: 10 weeks after termination of intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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