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Starting soon Phase 3

Metformin in Acute Ischemic Stroke

NCT07899307 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2026-11-01
Last updated
2026-10-27

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

PlaceboMetfomin →

Placebo: Placebo tablets will be provided

Metfomin: Incremental doses will be provided

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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: 1. Adults aged ≥18 years. 2. Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure. 3. Acute stroke is ischemic in origin and radiologically confirmed by Computed Tomography (CT) scan prior to enrolment. 4. Pre-stroke mRS score of 0 or 1 and first ever episode of stroke 5. National Institute Health Stroke Scale (NIHSS) of \>5 (NIHSS Level of Consciousness (1A) score must be \<2). 6. Patients undergoing intravenous thrombolysis will be included. Exclusion Criteria: * Any of the following: 1. Patients receiving endovascular therapy or are candidates for any surgical intervention for treatment of stroke. 2. Prior history of stroke of any type (ischemic/hemorrhagic/ subarachnoid hemmorhage) 3. Patients classified as comatose (NIHSS Level of Consciousness (1A) score ≥ 2). 4. Evidence of intracranial hemorrhage in the baseline CT. 5. Pregnancy and lactation. 6. Patients with co-morbid illnesses like chronic liver disease/chronic kidney disease/malignancy limiting their life expectancy. 7. Concurrent participation in any other therapeutic clinical trial/ rehabilitation trial. 8. 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.

Primary outcome measure(s)

  • modified Rankin Scale (0 to 6, with 0 being no disability and 6 being death) — 90 days
    Good outcome (defined as modified Rankin Scale of 0-1) at 90 days

Trial sites (4)

FacilityCityRegionStatus
Postgraduate Institute of Medical Education and Research Chandigarh Chandigarh
All India Institute of Medical Sciences New Delhi National Capital Territory of Delhi
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry Puducherry
Institute of Medical Sciences, Banaras Hindu University Varanasi India
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07899307 on ClinicalTrials.gov ↗ ← All trials in India