Homoarginine Supplementation in Patients After Stroke

Study Overview
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Brief Summary
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This study represents a follow-up of the previous study Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.

Official Title
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Homoarginine in Stroke (HiS) Study

Conditions
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Deficiency; Diet

Intervention / Treatment
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* Dietary Supplement: 125 mg L-homoarginine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score >= 4) or acute central retinal artery occlusion serum homoarginine </= 2.1 umol/L signed informed consent Exclusion Criteria: no acute stroke serum homoarginine > 2.1 umol/L heart failure (NYHA > 1) chronic kidney disease (GFR <60 mL/min) not competent pregnancy, lactation no or withdrawn signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized double-blind placebo controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo capsules containing lactose - oral once weekly administration for six month | Other: placebo<br>* capsules for oral supplementation<br>|
| Active Comparator: homoarginine<br>125 mg L-homoarginine supplement - oral once weekly administration for six month | Dietary Supplement: 125 mg L-homoarginine<br>* capsules for oral supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homoarginine serum concentration | Normalization of homoarginine serum concentration to levels >2.1 umol/L. | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intima-media thickness | Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery. | six month | 
| National Institute of Health Stroke Scale | National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0. | six month | 
| Modified Ranking Scale | Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death). | six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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homoarginine