Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Trial of Contrast-enhanced Sonothrombolysis in Acute Ischaemic Stroke
Brief Summary: BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with large clots may not achieve re-opening of the vessel and up to 40% of the patients may remain severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined with thrombolysis (sonothrombolysis) and increases the likelihood of functional independence at 3 months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances the thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced ultrasound may also accelerate clot break-up in the absence of thrombolytic drugs (contrast enhanced sonolysis = CES).

HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after symptom onset may be given safely to patients with acute ischemic stroke, both to those receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and will improve clinical outcome.

AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no ultrasound treatment in patients with acute ischemic stroke receiving or not receiving intravenous thrombolysis.

STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are bleeding complications (safety), brain damage (infarct size/location) and early clinical improvement (effect).


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desmoteplase | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desmoteplase | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desmoteplase | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
B: Arm Label: Ultrasound; Type: ACTIVE_COMPARATOR; Interventions: Other: Ultrasound | Arm Label: Sham ultrasound; Type: PLACEBO_COMPARATOR; Interventions: Other: Sham ultrasound | Intervention Type: OTHER; Name: Ultrasound; Assigned to Arm(s): Ultrasound | Intervention Type: OTHER; Name: Sham ultrasound; Assigned to Arm(s): Sham ultrasound
C: Arm Label: Desmoteplase, low dose; Type: EXPERIMENTAL; Interventions: Drug: Desmoteplase | Arm Label: Desmoteplase, high dose; Type: EXPERIMENTAL; Interventions: Drug: Desmoteplase | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): Desmoteplase, low dose | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): Desmoteplase, high dose | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desmoteplase | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desmoteplase | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Desmoteplase; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3

Answer: B