Homoarginine Supplementation in Patients After Stroke

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

July 18, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

August 22, 2018

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Homoarginine serum concentration[ Time Frame: six month ]

Normalization of homoarginine serum concentration to levels >2.1 umol/L.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Intima-media thickness[ Time Frame: six month ]
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.
National Institute of Health Stroke Scale[ Time Frame: six month ]
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.
Modified Ranking Scale[ Time Frame: six month ]
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).

Descriptive Information

Brief Title ^ICMJE

Homoarginine Supplementation in Patients After Stroke

Official Title ^ICMJE

Homoarginine in Stroke (HiS) Study

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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

Condition ^ICMJE

Intervention ^ICMJE

Dietary Supplement: 125 mg L-homoarginine
capsules for oral supplementation
Other: placebo
capsules for oral supplementation

Study Arms

Placebo Comparator: placebo
placebo capsules containing lactose - oral once daily for three days followed by six month once weekly administration
Active Comparator: homoarginine
125 mg L-homoarginine supplement - oral once daily for three days followed by six month once weekly administration

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2023

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - ischemic stroke (CT or MRI) - 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名