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Not yet taking people in IndiaPhase 3

Metformin Tested After Acute Ischemic Stroke

Tests metformin tablets against placebo in adults with acute ischemic stroke.

Plain-language title generated from the registry record
Registry title: Metformin in Acute Ischemic Stroke

Key facts

Where
Chandigarh, New Delhi, Puducherry, and Varanasi, IndiaSee the 4 sites
Phase
Phase 3

Where in India

  • Postgraduate Institute of Medical Education and ResearchChandigarh, IndiaNo longer taking part
  • All India Institute of Medical SciencesNew Delhi, IndiaNo longer taking part
  • Jawaharlal Institute of postgraduate medical education and researchPuducherry, IndiaNo longer taking part
  • Institute of Medical Sciences, Banaras Hindu UniversityVaranasi, IndiaNo longer taking part

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Trial details

Who runs it
All India Institute of Medical Sciences
Trial code
NCT07899307
Record updated
29 October 2026
Original description
The goal of this clinical trial is to study the efficacy of oral Metformin in Acute Ischemic Stroke (AIS). The main hypothesis is to study the efficacy of oral Metformin in patients with acute ischemic stroke presenting within 72 hours of onset in terms of goof modified Rankin scale (mRS) at 90 days. Researchers will compare placebo tablets.Read full original descriptionShow less

Efficacy of Oral Metformin in Acute Ischemic Stroke (AIS): a Multicentric Randomized Controlled Trial

The goal of this clinical trial is to study the efficacy of oral Metformin in Acute Ischemic Stroke (AIS). The main hypothesis is to study the efficacy of oral Metformin in patients with acute ischemic stroke presenting within 72 hours of onset in terms of goof modified Rankin scale (mRS) at 90 days. Researchers will compare placebo tablets.

Participants will randomised to Metformin or placebo in 1:1 ratio. Additionally, the blood sample will be collected to look for biomarkers hsCRP, Vitamin B12, and Holotranscobalamin at baseline and follow-up.

Inclusion: Patients with acute ischemic stroke(AIS) within 72 hours of symptom onset, ≥18 years of age, without large vessel occlusion (LVO) will be included in the study; All the following:; Adults aged ≥18 years; Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure; Acute stroke is ischemic in origin and radiologically confirmed by Computed Tomography (CT) scan prior to enrolment; Pre-stroke mRS score of 0 or 1 and first ever episode of stroke; National Institute Health Stroke Scale (NIHSS) of >5 (NIHSS Level of Consciousness (1A) score must be <2); Patients undergoing intravenous thrombolysis will be included.

Exclusion: Any of the following:; Patients receiving endovascular therapy or are candidates for any surgical intervention for treatment of stroke; Prior history of stroke of any type (ischemic/hemorrhagic/ subarachnoid hemmorhage); Patients classified as comatose (NIHSS Level of Consciousness (1A) score ≥ 2); Evidence of intracranial hemorrhage in the baseline CT; Pregnancy and lactation; Patients with co-morbid illnesses like chronic liver disease/chronic kidney disease/malignancy limiting their life expectancy; Concurrent participation in any other therapeutic clinical trial/ rehabilitation trial; Patients are already on metformin treatment. • A non-interventional arm of patients who fulfill the eligibility criteria and are already on metformin before the stroke will also be recruited for the purpose of prospective follow-up to assess the outcome at 90 days; Patients without diabetes will not be excluded from the study, as the doses of metformin to be used in our study have been amply used in other studies in non-diabetes conditions for indications like cancer, dementia, polycystic ovarian disease, obesity.

ClinicalTrials.gov NCT07899307