EUCTR2010-024541-67-GB
Active, not recruiting
Phase 1
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis – pilot phase - Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis
HS Greater Glasgow & Clyde R&D Office0 sites104 target enrollmentSeptember 28, 2011
ConditionsAcute Ischaemic StrokeMedDRA version: 14.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsMetalyse
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Ischaemic Stroke
- Sponsor
- HS Greater Glasgow & Clyde R&D Office
- Enrollment
- 104
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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