Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
23. december 2021 opdateret af: Ying Gao, Dongzhimen Hospital, Beijing
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014.
The study was designed to test efficacy of DGMI for IS.
Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups.
The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients.
Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged < 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
998
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Beijing, Kina, 100700
- Dongzhimen Hospital, Beijing University of Chinese Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 35 years of age or older, and gender not limited;
- Between 2 and 4 weeks onset of ischemic stroke;
- The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- Understand and voluntarily signed informed consent.
Exclusion Criteria:
- Known severe liver or kidney dysfunction;
- Known allergies for ingredients in the investigational product;
- Known medical condition likely to limit survival to less than 3 months;
- Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;
- Hemorrhage transformation after infarction, or bleeding tendency;
- Pregnancy or breastfeeding;
- Known lower extremity venous thrombosis;
- Having participated in others clinical trial within 1 month before randomization.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Diterpene ginkgolides meglumine injection
The intervention group received daily single infusions of 25 mg diterpene ginkgolides meglumine injection (DGMI) diluted with 250 ml of 0.9% sodium chloride injection for 14 days.
|
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
Andre navne:
|
|
Aktiv komparator: Ginaton
The control group received once or twice a day infusion of 35-60mg Ginaton diluted with 250 ml of 0.9% sodium chloride injection for 14 days.
|
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Excellent functional outcome
Tidsramme: 90 days
|
Excellent functional outcome defined as an Modified Rankin Scale (mRS) score ≤ 1 at 90 days(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death)
|
90 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurological deficit amelioration
Tidsramme: 14 post-randomization days, 90days
|
neurological deficit amelioration, which was defined as a change in the National Institutes of Health Stroke Scale (NIHSS) score (range = 0-42, with higher scores indicating more severe strokes) from baseline to D14
|
14 post-randomization days, 90days
|
|
Patient quality of life
Tidsramme: 14 post-randomization days, 90days
|
Patient quality of life, as measured using the EuroQol questionnaire [consisting of two parts: EuroQol-5 Dimension(EQ-5D) and EQ visual analog scale (EQ-VAS)].
A value of 100 on this scale indicates a perfect score for health, whereas a score of 0 indicates death.
The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).
|
14 post-randomization days, 90days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2013
Primær færdiggørelse (Faktiske)
1. april 2014
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
6. december 2021
Først indsendt, der opfyldte QC-kriterier
23. december 2021
Først opslået (Faktiske)
27. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TJ2013012
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .