Safe Implementation of Thrombolysis in Stroke - Monitoring Study

NCT02229812 | Completed

• 1 other identifier: 135.313
• Study Type: observational
• Target: 6,475
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom onset in acute ischemic stroke patients

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Occurrence of symptomatic intracerebral hemorrhage (SICH)

  up to 36 hours

• Mortality rate

  3 months

Secondary Outcomes (1)

• Independence for activities of daily living

  3 months

Study Arms (1)

thrombolytic therapy in stroke

Drug: alteplase

Interventions

alteplase DRUG

thrombolytic therapy in stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

acute stroke patients in the European Union

You may qualify if:

• Female or male in-patient
• Age 18 - 80 years
• Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment
• Stroke symptoms present for at least 30 minutes that had not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder
• Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval of data and follow up procedures, according to the regulations in participating countries
• Willingness and ability to comply with the study protocol

You may not qualify if:

• Evidence of intracranial hemorrhage (ICH) on the CT-scan
• Symptoms of ischemic attack began more than 3 hours 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 and/or by appropriate imaging techniques
• Seizure at onset of stroke
• Symptoms suggestive of subarachnoid hemorrhage, 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
• Patients with any history of prior stroke and concomitant diabetes
• Prior stroke within the last 3 months
• Platelet count of 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
• Known hemorrhagic diathesis
• Patients receiving oral anticoagulants, e.g. warfarin sodium
• Manifest or recent severe or dangerous bleeding

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: December 1, 2002
• Primary Completion: July 1, 2006
• Last Updated: September 1, 2014

Record last verified: 2014-08