At a glance
ClinicalIndex Comparison Record- ✓Acute ischemic stroke with planned IV tPA treatment and measurable neurological deficit of sudden onset
- ✓NIHSS score ≤21 for left hemisphere strokes, ≤16 for other locations
- ✓Age 18-85 years, inclusive
- ✓Body weight greater than 50 kg
- ✕History of intracranial hemorrhage (ICH) at any time
- ✕Evidence of acute ICH on head CT or MRI
- ✕Recent major surgery, serious trauma, or lumbar puncture within 14 days
- ✕Intracranial surgery, intraspinal surgery, or serious head trauma requiring hospitalization within past 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST)
In Brief
A Phase 2 clinical trial evaluating Aspirin, tinzaparin sodium, and 1 other intervention for Ischemic Stroke. Completed, enrolled 18 participants across 3 sites.
Detailed Summary
Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine alteplase, also known as tPA , is the standard drug used to treat patients with acute ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA alone is effective in treating the fibrin part of the clot approximately 30% of the time, adding other commercially available drugs such eptifibatide to treat other clot components may improve the effectiveness of iv tPA therapy. This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance imaging (MRI) criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose.
Study Details
Timeline
Interventions
A single 81 mg aspirin tablet orally (or rectal suppository equivalent dose) given as soon as possible after start of standard iv tPA and consent.
A single weight-based dose of 80 anti-Xa International Units/kilogram (IU/kg)administered by subcutaneous (SQ) injection.
Eptifibatide administered iv according to dose escalation group. The five dosing groups for eptifibatide are 0, 45 µg/kg bolus, 90 µg/kg bolus, 90 µg/kg bolus plus 0.25 µg/kg/min infusion for 24 hours, and 90 µg/kg bolus plus 0.5 µg/kg/min infusion for 24 hours.