Conditions: Acute Ischemic Stroke
Keywords: Fibrinolysis enhancer TAFIa inhibitor Developmental Phase I
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 42
Healthy volunteers: no

Brief summary:
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.

Detailed description:

Arms:
arm 1: Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours arm 2: Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours arm 3: Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours arm 4: Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours arm 5: Participants receive saline by intravenous infusion over six hours

Interventions: intervention 1: DS1040b intervention 2: Placebo
Intervention descriptions: intervention 1: DS-1040b in solution for intravenous infusion intervention 2: Saline solution for intravenous infusion

Protocol document:
Prot_SAP_000.pdf: