THR-18's Pharmacokinetics and Pharmacodynamics in Subjects With Acute Ischemic Stroke Treated With tPA
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the experimental drug "THR-18" given together with the
drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator
is also called "tPA".
Strokes often result from blockade of blood supply caused by blood clots forming within the
blood vessel feeding the brain. Such strokes are called "Ischemic strokes". Treatment of
these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before
further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when
it is injected into a vein shortly after the stroke starts. However, along with breaking up
the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.
THR-18, the drug tested in this study, is meant to bind to tPA and reduce its adverse effects
without stopping tPA's breaking up of the blocking blood clot.
The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic
stroke patients who are treated in parallel with tPA. Another purpose of this study is to
investigate levels of THR-18 and tPA in the blood stream at different time points after they
are injected, at the same time, into a vein. In addition, this study will measure tPA's
effect on blood clot dissolution when tPA is given with and without THR-18. The study will
also study the effect THR-18 may have on signals of brain damage that can be found in the
blood after stroke: these signals of brain damage are small proteins called S100B and matrix
metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain
is injured.
The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo
is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be
tested, one after the other, in three groups of patients. In each group, some patients will
receive THR-18 and some will receive placebo. This clinical study will be conducted only at
one hospital in the Ukraine. In total, 30 patients are planned to participate in this study.
These patients will be in the hospital for at least 3 days after receiving the study
treatment. Then, about 1 month later, they will be invited for a last follow-up visit.