Status:
COMPLETED
Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke
Lead Sponsor:
Angel Chamorro, MD
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether the combined treatment with Uric Acid and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke patients treated withi...
Detailed Description
Oxidative stress is a major contributor to brain damage in patients with ischemic stroke. Uric acid (UA) is an endogenous product derived from the metabolism of purins which in man is responsable of t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age older than 18 years old.
- Acute ischemic stroke treated with rtPA within the first 4.5 hours of clinical onset. Baseline National Institute of Health Stroke Scale (NIHSS) \>6 and \<25, and modified Rankin Scale (mRS) of 2 prior to the stroke.
- Cranial CT disclosing the absence of blood in the CNS.
- Informed consent.
- Exclusion criteria:
- Presence of any of the valid exclusion criteria for the administration of rtPA in the current clinical practise.
- History of gout with or without history of gouty nephropathy, or uric lithiasis. Asymptomatic hiperuricemia under chronic treatment with allopurinol, or chronic treatment with lithium.
- Chronic renal insufficiency (baseline creatinine \> 1,5mg/dl).
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00860366
Start Date
June 1 2011
End Date
October 1 2013
Last Update
March 10 2015
Active Locations (10)
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1
Hospital General Universitario de Albacete
Albacete, Albacete, Spain, 02006
2
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital de la Santa Creu y Sant Pau
Barcelona, Barcelona, Spain, 08025
4
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036