Overview

Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke

Status:
Completed

Trial end date:
2013-10-01

Target enrollment:
0

Participant gender:
All

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 within the first 4.5 hours of symptoms onset.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Angel Chamorro, MD

Collaborator:

Carlos III Health Institute

Treatments:

Lithium Carbonate
Mannitol
Uric Acid

Criteria

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).