CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 808 enrolled
Drug / intervention
rt-PA +1 moredrug
Likely dose
rt-PA 0.9mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03740958
NCT03740958Phase 4Completed

Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study

General Hospital of Shenyang Military Region·interventional·Posted Nov 14, 2018·Updated Feb 22, 2022

In Brief

A Phase 4 clinical trial evaluating rt-PA and Argatroban for Stroke. Completed, enrolled 808 participants across 1 site.

Detailed Summary

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world. Recent studies have found that the combined application of argatroban and rt-PA in the treatment of AIS might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening. Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of AIS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 14, 2018
Enrollment StartDec 21, 2018
Primary CompletionJan 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.6 years ago

Interventions

rt-PAdrug

Intravenous throbolysis with 0.9mg/kg rtPA

Argatrobandrug

100 ug/kg bolus over 3 to 5 minutes was administered intravenously, followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)