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NCT02448069 · ClinicalTrials.gov registry record · Phase 2
Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02448069 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 10 participants.
The verdict
NCT02448069, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: Our prior work with combination argatroban + recombinant tissue plasminogen activator (rt-PA) (ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized low and high-dose study; n=90), demonstrated safety of the two drugs when delivered concomitantly and recanalization rates were greater than with historical controls. Further, interim analysis of neurological outcomes at 75 patients of the randomized Phase IIb trial, demonstrated a signal of efficacy when compared to control (rt-PA alone) patients. However, rt-PA fails to reperfuse brain in most patients with large thrombi, prompting several recent randomized clinical trials which have demonstrated that intra-arterial therapy (IA) following rt-PA substantially improves outcome in patients with distal carotid or proximal middle cerebral artery occlusions. As a result, rt-PA + IA has become the new standard-of-care for many patients with large arterial occlusions such as those treated in ARTSS-1 and 2. Therefore, this study is necessary to explore the feasibility and safety of adding Argatroban in acute ischemic stroke patients who also receive rt-PA followed by IA. Primary Objective: To demonstrate the feasibility and safety of treating stroke patients with Argatroban who undergo usual thrombolysis care (intravenous rt-PA followed by IA). Secondary Objectives: 1. Assess rates of ultra-early recanalization at commencement of IA; 2. Assess the completeness and pattern of reperfusion as obtained by IA; 3) Assess clinical outcome
Interventions
- DRUG Argatroban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02448069
The ClinicalTrials.gov registry entry for NCT02448069 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Argatroban is the first listed.
NCT02448069 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02448069 about?
NCT02448069 is a clinical study titled "Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke". Background: Our prior work with combination argatroban + recombinant tissue plasminogen activator (rt-PA) (ARTSS-1: Phase IIa low-dose safety study; n=65 and ARTSS-2: Phase IIb randomized low and high-dose study; n=90), demonstrated safety of the two drugs when delivered concomitantly and recanaliz...
What is the current status of trial NCT02448069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-05. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02448069?
The interventions under investigation include: Argatroban (DRUG).
Who is sponsoring clinical trial NCT02448069?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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