Ischaemic stroke MedDRA version: 8.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS
Conditions
Interventions
Trade Name: Aggrenox®
Product Name: Aggrenox®
Pharmaceutical Form: Prolonged-release capsule*
INN or Proposed INN: Dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria To be eligible, the following inclusion criteria must be met: 1.) Adult inpatient 2.) Clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Symptoms must be distinguishable from an episode of generalized ischaemia (i.e. syncope), seizure, or migraine disorder. 3.) Time of stroke onset is known. Symptoms of ischaemic attack began at a time point what makes the start with study medication within 24 hours possible. When a stroke happened during sleep, bedtime is assumed as time of onset. 4.) NIHSS assessment equal or below 20 points (at pre-screening). 5.) Treatment indication is given either to valid German SPC of Aggrenox capsules or to ASS STADA 100 mg tablets. 6.) A contraindication for stroke lysis is given 7.) Patients are able to swallow either medication or administration of the substances via a nasogastral tube is possible. 8.) Signed and witnessed written informed consent obtained prior to the first study intervention. Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral, witnessed (preferably by relatives) informed consent. These patients have to make clear without doubt that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.) Intracranial haemorrhage on CT-scan present. 2.) A contraindication for Aggrenox or ASA is given: · Hypersensitivity to any of the components of the product or salicylates · Active gastric or duodenal ulcers · Bleeding disorders · Pregnancy during the third trimester · Hereditary problems of fructose intolerance and / or galactose intolerance, e.g. galactosaemia 3.) As to the discretion of the investigator, precautions and warnings for ASA and Aggrenox may lead to exclusion of patients as there are: · Dipyridamole should be used with caution in patients with severe coronary artery disease, including unstable angina and recent myocardial infarction, left ventricular outflow obstruction, or haemodynamic instability (e.g. decompensated heart failure). · In patients with myasthenia gravis readjustment of therapy may be necessary after changes in dipyridamole dosage. · Long-term treatment of elderly patients suffering from ascending cholangitis should be considered with caution. A small number of cases has been reported in which unconjugated dipyridamole was incorporated into gallstones to a variable extent (up to 70% by dry weight of stone). · Due to the ASA component, Aggrenox should be used with caution in patients with asthma, allergic rhinitis, nasal polyps, chronic or recurring gastric or duodenal complaints, impaired renal or hepatic function or glucose-6-phosphate dehydrogenase deficiency. · Caution is advised in patients hypersensitive to NSAIDs. · Dipyridamole and salicylates are excreted in breast milk. Aggrenox should only be administered during early pregnancy or lactation if considered essential by the physician in terms of benefit and risk. · Caution should be advised in patients receiving concomitant medication which may increase the risk of bleeding, such as anti-platelet agents (e.g. clopidogrel, ticlopidine) or selective serotonin reuptake inhibitors (SSRIs). See section 4.2.2 for restrictions on concomitant medication. 4.) Patient underwent any thrombolysis therapy (e. g. for stroke, myocardial infarct, deep vein thrombosis) within 24 hours before medication. 5.) Any antithrombotic treatment has been planned or started (Note: low-dose thrombosis prevention which is permitted in combination with ASA treatment is acceptable). 6.) A platelet inhibiting therapy with ASA doses of more than 100 mg per day, or with Clopidogrel at any dose has been planned or started. 7.) Current or recent (within 3 months) participation in another clinical study with a non-registered drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to initiation after a 7-day ASA treatment outside off an acute stroke unit.;Primary end point(s): The study is powered on tele-mRS on day 90 – centralised, blinded assessment. But since this study has an exploratory character and does not serve for regulatory purposes, no primary endpoint is defined. All endpoints that will be investigated are described in the protocol in section 2.3.1. ;Secondary Objective: Secondary efficacy endpoints 1.) Tele-mRS on day 8 and 90 – centralised, blinded assessment 2.) Change in mRS and NIHSS from baseline to day 8 and 90 – assessment by investigator 3.) Time to first relevant event (vascular or non-vascular death, non-fatal stroke, non-fatal myocardial infarction, bleeding complications) – centralised, blinded assessment by an adjudicating committee 4.) Neuroanatomical and neurofunctional changes from baseline to day 8 as assessed by MRI parameters – centralised, blinded assessment by a central radiology centre 5.) Changes of special biochemical laboratory values (MMP-9, MCP-1 and CRP) from baseline to day 8 – centralised, blinded assessment by a specialised central clinical laboratory 6.) Premature study discontinuations due to AEs Secondary safety endpoints 7.) Number and kind of adverse events (AEs) | — |
Countries
Germany
Outcome results
None listed