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ARTSS-2: A Pilot, Phase 2b, Randomized, Multi-center Trial of Argatroban in Combination With Recombinant Tissue Plasminogen Activator for Acute Stroke
Randomized controlled clinical trial to estimate overall treatment benefit (improvement in disability) among stroke patients treated with rt-PA who are randomized to also receive either low-dose Argatroban, high-dose Argatroban or neither.
Details
| Lead sponsor | Andrew D. Barreto, MD |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 90 |
| Start date | 2011-10 |
| Completion | 2015-06-11 |
Conditions
- Ischemic Stroke
Interventions
- Low Dose Argatroban
- High Dose Argatroban
- rt-PA (alteplase)
Primary outcomes
- Number of Participants With 0 or 1 on Modified Rankin Scale — 90 days
Excellent functional outcome as measured by the number of patients with a 0 or 1 on the modified Rankin Scale (mRS) at day 90 as assessed by study personnel blinded to treatment. - Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration — 48-hours
Symptomatic intracranial hemorrhage (sICH) is defined as any evidence of bleeding on CT scan that in the opinion of the treating physician and/or an independent safety monitor is associated with a clinically significant neurological worsening. A four or more point increase in the NIHSS score from baseline (or last score obtained prior to blood found on CT scan) to subsequent CT scan at the time of potential worsening can be used as a guide by the clinical investigator or safety monitor for what represents a significant worsening in neurologic status but sICH can include any worsening deemed significant by the clinical investigator or independent safety monitor.
Countries
United States