A post marketing surveillance registry of tenecteplase (a clot busting medication) in acute ischemic stroke for adult patients.

Active Post Marketing Study of Tenecteplase (0.2 mg/kg of the body weight) within 4.5 h of onset of Acute Ischemic Stroke Symptoms - IRIS - TNK Registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/11/010380

Enrollment

1000

Registered

2017-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: null- Adult (age 18 years or above)Acute ischemic stroke patients presenting with symptom of stroke and eligible for thrombolysis

Interventions

Intervention1: NIL: NIL Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: a. Per the approved prescribing information for tenecteplase (Brand Name- Tenectase) b. Willingness to provide a signed undertaking to collect and treat their data statistically for a scientific publication

Exclusion criteria

Exclusion criteria: As per the approved prescribing information for tenecteplase (Brand Name- TENECTASE)

Design outcomes

Primary

Measure	Time frame
Symptomatic Intra-cranial Hemorrhage within 36 Â±6 hours after start of thrombolysis treatmentTimepoint: Symptomatic Intra-cranial Hemorrhage within 36 Â±6 hours after start of thrombolysis treatment	—

Secondary

Measure	Time frame
Barthel IndexTimepoint: at day 90;mRS 0-2 (Functional Independence)Timepoint: at day 7 and day 90;mRS score of 0-1 (Excellent Outcome)Timepoint: at day 7 and day 90;NIHSS improvement more than or equal to 4 points or 0Timepoint: at 24 hours, 7 days (or day of discharge) post treatment initiation;NIHSS improvement more than or equal to 8 points or 0Timepoint: at 24 hours, 7 days (or day of discharge) post treatment initiation	—

Measure

Time frame

Barthel IndexTimepoint: at day 90;mRS 0-2 (Functional Independence)Timepoint: at day 7 and day 90;mRS score of 0-1 (Excellent Outcome)Timepoint: at day 7 and day 90;NIHSS improvement more than or equal to 4 points or 0Timepoint: at 24 hours, 7 days (or day of discharge) post treatment initiation;NIHSS improvement more than or equal to 8 points or 0Timepoint: at 24 hours, 7 days (or day of discharge) post treatment initiation

—

Countries

India

Contacts

Public ContactRajesh Kumar Singh

Gennova Biopharmaceutical Limited

rajeshkumar.singh@gennova.co.in02039821300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026