Randomized, double blind, mutlicenter, multinational, placebo controlled, single parallel escalating dose safety and efficacy study of ACT017 used as an add-on therapy on top of standard of care of acute ischemic stroke

Phase 2

Withdrawn

• Conditions: stroke; Acute Ischemic Stroke; 10047066

• Registration Number: NL-OMON49177
• Lead Sponsor: ACTICOR BIOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1 Patients presenting with an acute disabling ischemic stroke in either the
anterior or posterior circulation.The time of onset is known or if unknown, the
last time the patient was seen well, was at most 4.5 hrs before confirmation of
the diagnosis enabling the initiation of alteplase administration within this
time-frame;
2. Patients presenting at least a NIHSS * 6 prior to thrombolysis with tPA;
3. Patients eligible for, or administered thrombolysis treatment with tPA;
4. Patients who can undergo mechanical thrombectomy if eligible;

Exclusion Criteria

1.Coma, and/or NIHSS >25;
2.Prior ischemic stroke within the past 3 months with pre-stroke mRS known to
be > 2;
3. Baseline CT-scan evaluation: more than 1/3 of the middle cerebral artery)
regions of clear hypodensity on the baseline imaging;
4. Significant mass effect with midline shift;
5. Stroke of hemorrhagic origin;
6. Contra-indications to thrombolysis with tPA:
7. Patients receiving a dual antiplatelet treatment;
8. Cardiopulmonary resuscitation within the past 10 days;
9. Epileptic seizure at the onset of symptoms;
10. Known severe (grade 3 and above) renal impairment or Glomerular Filtration
Rate < 30 ml/min/1.73 m2 or Serum Creatinine > 2X ULN (1.2 mg/dL for men and
1.0 mg/dL for women) at screening;

Study & Design

• Study Type: Interventional
• Study Design: Not specified