A Pilot study to compare standard clot-busting drug treatment for stroke (alteplase) with a newer drug treatment (tenecteplase)

Phase 1

• Conditions: Acute Ischaemic Stroke; MedDRA version: 14.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-024541-67-GB
• Lead Sponsor: HS Greater Glasgow & Clyde R&D Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

•Clinical diagnosis of supratentorial acute ischaemic stroke
•Male or non-pregnant female =18 years of age
•Within 4.5 hours of onset as defined by time since last known well
•CTP and CTA examinations acquired prior to treatment

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

•Contraindications to thrombolytic drug treatment for stroke
oEvidence of intracranial haemorrhage or significant non-stroke intracranial pathology on pre-treatment CT
oEstablished hypodensity on pre-treatment brain CT of more than one third of the MCA territory or ASPECT score <4 (sulcal effacement or loss of grey-white differentiation in cortical territories alone are not counted towards ASPECT score)
oHypodensity consistent with recent cerebral ischaemia other than the presenting event
oIf on warfarin, INR <1.4
oSignificant abnormality of coagulation parameters pre-treatment (prolonged INR or APTT, or low platelet count<100x109/l)
oClinical history suggestive of SAH even if no blood is evident on CT
oMajor surgery within previous 1 month
oDependent (mRS 3-5) pre-stroke
oBlood glucose <2mmol/l or >22mmol/l
oPregnancy
•Known impaired renal function (eGFR <30ml/min) precluding contrast CT
•Known allergy to radiological contrast
•Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy = 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified