A Study of the Safety, Imaging and Clinical Outcomes of THR-18 in Acute Stroke Subjects Treated With tPA
Status:
Unknown status
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
This study will 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 reduce tPA's adverse effects without
stopping tPA's breaking up of the blocking blood clot.
The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke patients
who are treated in parallel with tPA, to measure tPA's effect on blood clot dissolution when
this drug is given with and without THR-18, and to study the effects THR-18 may have on
signals of brain damage as seen on brain computerized tomography (a type of brain x-ray)
after treatment with tPA with and without THR-18. Patients will also be evaluated for their
ability to perform daily activities after the stroke following tPA treatment with and without
THR-18.
The 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. One dose of THR-18 will be tested,
in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients
are planned to participate in this study. The decision whether a patient will receive THR-18
or placebo will be based on chance (this procedure is called "randomization"). This clinical
study will be conducted only at one hospital, in the Republic of Moldova. The 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.