NCT07899307Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Efficacy of Oral Metformin in Acute Ischemic Stroke (AIS): a Multicentric Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Oct 2030
- Lead sponsor
- All India Institute of Medical Sciences
- Diseases
- Stroke
- NCT number
- NCT07899307
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 440
- From 1 Nov 2026 to the primary completion date, 30 Oct 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Postgraduate Institute of Medical Education and Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Jawaharlal Institute of postgraduate medical education and research Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| Institute of Medical Sciences, Banaras Hindu University Coordinator of this site? Confirm its status | Varanasi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.