Clinical trial NCT00153036 (phase 3, status: completed)
Conditions: cerebrovascular accident
ICD codes: A52.05, I67.81, I67.89, I67.9, I67.841, I67.858, I67.848
Drugs: rt-pa 0.9 mg/kg verum or placebo intravenous
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Female or male inpatients

          -  Age: 18 - 80 years.

          -  Clinical diagnosis of ischemic stroke causing a measurable neurological deficit
             defined as impairment of language, motor function, cognition and/or gaze, vision or
             neglect. Ischemic stroke is defined as an event characterized by the sudden onset of
             an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT
             scan excludes hemorrhage.

          -  Onset of symptoms between 3 and 4 hours prior to initiation of administration of study
             drug.

          -  Stroke symptoms are to be present for at least 30 minutes and have not significantly
             improved before treatment. Symptoms must be distinguishable from an episode of
             generalized ischemia (i.e. syncope), seizure, or migraine disorder.

          -  Patient is willing to participate voluntarily and to sign a written patient informed
             consent. Informed consent will be obtained from each patient or the subject's legally
             authorized representative or relatives, or deferred where applicable, according to the
             regulatory and legal requirements of the participating country.

          -  Patients who are unable to sign but who are able to understand the meaning of
             participation in the study may give an oral witnessed informed consent. These patients
             have to make clear undoubtfully that they are willing to participate voluntarily and
             must be able to understand an explanation of the contents of he information sheet.

          -  Willingness and ability to comply with the protocol.

        Exclusion Criteria:

          -  Evidence of intracranial hemorrhage (ICH) on the CT-scan.

          -  Symptoms of ischaemic attack began more than 4 hours and 30 minutes prior to infusion
             start or when time of symptom onset is unknown.

          -  Minor neurological deficit or symptoms rapidly improving before start of infusion.

          -  Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging
             techniques.

          -  Epileptic seizure at onset of stroke

          -  Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal.

          -  Administration of heparin within the previous 48 hours and a thromboplastin time
             exceeding the upper limit of normal for laboratory

          -  History of prior stroke and concomitant diabetes. * Prior stroke within the last 3
             months

          -  Platelet below 100,000/mm3. * Systolic blood pressure >185 mmHg or diastolic blood
             pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to
             these limits.

          -  Blood glucose <50 or > 400 mg/dl (< 2.77 or > 22.15 mmol / l). * Known haemorraghic
             diathesis

          -  Patients receiving oral anticoagulants. * Manifest or recent severe or dangerous
             bleeding

          -  Known history of or suspected intracranial haemorrhage

          -  Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from
             aneurysm

          -  History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or
             spinal surgery)

          -  Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate
             haemorrhagic retinopathy)

          -  Recent (less than 10 days) traumatic external heart massage, obstetrical delivery,
             recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein
             puncture.

          -  bacterial endocarditis, pericarditis.* Acute pancreatitis

          -  Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal
             varices, arterial- aneurysm, arterial/venous malformation

          -  Neoplasm with increased bleeding risk