Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke "ARTSS-2"

Terminated

Phase 2 Results N/A

Trial Description

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.

Detailed Description

Recombinant tissue plasminogen activator (rt-PA), the only proven treatment for acute ischemic stroke, fails to reperfuse brain in most patients with large thrombi. In our Phase 2a low-dose safety study (n=65), the two drugs appeared safe when delivered concomitantly and recanalization rates were greater than historical controls. This study will provide evidence-based hypotheses and data needed to design a larger definitive trial.
The purpose of this trial is 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.

Trial Stopped: Begin a new study to test the safety of combining IA with tPA and Argatroban.

Conditions

Interventions

  • Argatroban (Novastan┬«)Drug
    Intervention Desc: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.
    ARM 1: Kind: Experimental
    Label: Low dose Argatroban
    Description: 100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.
    ARM 2: Kind: Experimental
    Label: IV tPA only
    Description: Standard of care
    ARM 3: Kind: Experimental
    Label: High dose Argatroban
    Description: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients with 0 or 1 on Modified Rankin Scale 90 days No
Secondary Incidence of hemorrhage 90 days Yes
Secondary Rates of recanalization 2 hours No
Secondary Improvement in neurological deficits 90 days No
Secondary Cost effectiveness 90 days No

Sponsors