Mildronate for Acute Ischemic Stroke
Sleutelwoorden
Abstract
Omschrijving
A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.
Datums
| Laatst geverifieerd: | 03/31/2013 |
| Eerste ingediend: | 04/09/2013 |
| Geschatte inschrijving ingediend: | 04/09/2013 |
| Eerst geplaatst: | 04/11/2013 |
| Laatste update ingediend: | 04/09/2013 |
| Laatste update geplaatst: | 04/11/2013 |
| Werkelijke startdatum van het onderzoek: | 06/30/2008 |
| Geschatte primaire voltooiingsdatum: | 03/31/2010 |
| Geschatte voltooiingsdatum van het onderzoek: | 03/31/2010 |
Conditie of ziekte
Interventie / behandeling
Drug: mildronate
Drug: cinepazide maleate
Drug: aspirin
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: mildronate infusion of mildronate | Drug: mildronate |
| Active Comparator: cinepazide maleate infusion of cinepazide maleate | Drug: cinepazide maleate |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: - (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients >= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value. Exclusion Criteria: - (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months. |
Resultaat
Primaire uitkomstmaten
1. the modified Rankin scale [3 months]
Secundaire uitkomstmaten
1. NIHSS scores [15 days]
2. the Barthel index [15 days]
