Homoarginine Supplementation in Patients After Stroke
HiS
Homoarginine in Stroke (HiS) Study
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2018
CompletedStudy Start
First participant enrolled
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJuly 2, 2021
June 1, 2021
4.3 years
July 18, 2018
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Homoarginine serum concentration
Normalization of homoarginine serum concentration to levels \>2.1 umol/L.
six month
Secondary Outcomes (3)
Intima-media thickness
six month
National Institute of Health Stroke Scale
six month
Modified Ranking Scale
six month
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo capsules containing lactose - oral once weekly administration for six month
homoarginine
ACTIVE COMPARATOR125 mg L-homoarginine supplement - oral once weekly administration for six month
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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- no or withdrawn signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Hamburg
Hamburg, 20246, Germany
Related Publications (1)
Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20.
PMID: 27434056BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2018
First Posted
October 2, 2018
Study Start
August 22, 2018
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
July 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share