Aspirin and Clopidogrel in patients with Tubercular meningitis

A Randomised Trial To Assess The Efficacy Of Add On Therapy With Aspirin Or Clopidogrel To The Standard Medical Therapy Alone In Patients With Tubercular Meningitis: ACT TBM - ACT TBM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020488

Enrollment

260

Registered

2019-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere

Interventions

Intervention1: Standard 4 drug ATT [rifampicin (10 mg/kg, based on weight)

isoniazid (5mg/kg, based on weight)

pyrazinamide (15-30 mg/kg, based on weight)

ethambutol (15 mg/kg, based on weight) or streptomycin 0.75-1gm/day]

steroid and add on Aspirin 75mg per day for three months. Standard 4 drug ATT, steroid and add on Clopidogrel 75mg per day for three months. Each patient will receive 4 drug ATT for 2 months and 3

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 years old or older 2.Willing to participate in the study by signing informed consent 3.Clinically diagnosed as TB meningitis by standard criteria using clinical, CSF and radiological findings using modified Ahujaâ??s criteria

Exclusion criteria

Exclusion criteria: 1. Failure to perform lumbar puncture 2. Current use of antiplatelet agents 3. Contraindication for the use of aspirin or clopidogrel 4. Known hypersensitivity to aspirin or clopidogrel 5. Active bleeding 6. HIV positivity 7. Disseminated tuberculosis other than pulmonary TB. 8. Proven MDR, XDR TB. 9. Confirmed meningitis other than TB 10. Already on treatment for tuberculosis for more than 15 days prior to current admission 11. Pregnant or lactating females 12. Hepatic insufficiency (ALT >5x upper normal limit)

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Outcome Measure: 1. Occurrence of cerebral infraction on MRI Brain and / or clinical evidence of stroke at 1 and 3 months of follow up. Primary Safety Outcome Measure: 1. Any major or minor bleeding 2. Any hematemesis or intracerebral haemorrhage(parenchymal, subarachnoid, subdural, extradural) Timepoint: 1, 3 months.	—

Secondary

Measure	Time frame
1. Mortality at 1and 3 months of follow up. 2. Morbidity as assessed using modified Rankin score (mRS) at 3 ,6 months of follow up. 3. Difference between aspirin and clopidogrel in the occurrence of cerebral infraction or stroke, mortality and functional outcome. 4. Longterm follow up data upto one year shall be observed for all possible patients for mortality and morbidity on follow up. Timepoint: 1, 3, 6 months	—

Measure

Time frame

1. Mortality at 1and 3 months of follow up. 2. Morbidity as assessed using modified Rankin score (mRS) at 3 ,6 months of follow up. 3. Difference between aspirin and clopidogrel in the occurrence of cerebral infraction or stroke, mortality and functional outcome. 4. Longterm follow up data upto one year shall be observed for all possible patients for mortality and morbidity on follow up. Timepoint: 1, 3, 6 months

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Countries

India

Contacts

Public ContactRohit Bhatia

AIIMS. New Delhi

rohitbhatia71@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026