An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke

NCT02229890 | Completed

• 1 other identifier: 135.317
• Study Type: observational
• Target: 593
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute ischemic stroke

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition)

  up to 7 days

• Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition)

  up to 36 hours

• Mortality rate

  up to 6 months

Secondary Outcomes (1)

• Number of patients with functional independence (independence for activities of daily living)

  3 months

Study Arms (1)

Acute ischemic stroke within three hours after symptom onset

Drug: alteplase

Interventions

alteplase DRUG

Also known as: Actilyse®

Acute ischemic stroke within three hours after symptom onset

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 ischemic stroke within three hours after symptom onset treated at stroke centers

You may qualify if:

• Female or male inpatients
• Age 18 - 80 years
• Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment
• Stroke symptoms present for at least 30 minutes and 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 and storage of data and follow up procedures, according to the regulations in participating countries
• Willingness and ability to comply with the observational 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
• Symptoms of acute ischemic stroke that were either rapidly improving or only minor before start of infusion
• Severe stroke as assessed clinically and/or by appropriate imaging techniques
• Seizure at onset of stroke
• History of previous stroke or serious head-trauma within three months
• Administration of heparin within the previous 48 hours preceding the onset of stroke with an elevated activated thromboplastin time (aPTT) at presentation
• A combination of previous stroke and concomitant diabetes
• Platelet count of below 100,000/mm³
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, or aggressive management (repeated IV medication) necessary to reduce BP to these limits.
• Blood glucose \<50 or \> 400 mg/dl
• Significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
• Patients receiving oral anticoagulants, e.g. warfarin sodium (INR\>1.3)
• History or evidence or suspicion of intracranial hemorrhage including sub-arachnoid hemorrhage
• Severe uncontrolled arterial hypertension

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 3, 2014
• Study Start: June 1, 2006
• Primary Completion: March 1, 2009
• Last Updated: September 3, 2014

Record last verified: 2014-08