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Clinical Trials/CTRI/2019/05/019305
CTRI/2019/05/019305
Not yet recruiting
Phase 2

Safety and efficacy of N-Acetylcysteine (NAC) as an adjunct to standard treatment in patients with acute ischemic stroke â?? A Phase II Randomized Controlled Trial

AIIMS New Delhi0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries
Sponsor
AIIMS New Delhi
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
AIIMS New Delhi

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients presenting with anterior circulation acute ischemic stroke within 4\.5 hours of stroke onset.
  • •2\.Age is \>\=18 years and upto 80 years.
  • •3\.Eligible using standard criteria to receive intravenous (IV) thrombolysis with alteplase ( tissue plasminogen activator)
  • •4\.Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
  • •5\.Where indicated, endovascular thrombectomy can commence (groin puncture) within 6 hours of stroke onset and in highly selected cases up to 24hours based on imaging inclusion criteria.
  • •6\.Patients with ASPECTS score \> or equal to 7\.

Exclusion Criteria

  • •1\. Intracranial hemorrhage (ICH) identified by CT or MRI
  • •2\. Pre\-stroke mRS score of \>\= 2 (indicating previous disability)
  • •3\. Hypodensity in \>1/3 MCA territory on non\-contrast CT
  • •4\. Angiographic evidence of carotid dissection
  • •5\. Contra indication to imaging with contrast agents
  • •6\. Any terminal illness such that the patient would not be expected to survive long.
  • •7\. Pregnant women
  • •8\. Previous stroke within last three months
  • •9\. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio\-venous (AV) malformation, aneurysm, or cerebral neoplasm (at the discretion of investigator)
  • •10\. Current use of oral anticoagulants and a prolonged prothrombin time (INR \> 1\.7\)

Outcomes

Primary Outcomes

Not specified

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