18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)Primary· Up to 1 year.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
1. \- No significant disability. Able to carry out all usual activities, despite some symptoms.
2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. \- Moderate disability. Requires some help, but able to walk unassisted.
4. \- Mode
Group
Value
95% CI
IV Rt-PA Cohort
11.1
10.0 – 12.2
Non-reperfusion Cohort
12.2
11.1 – 13.3
Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 YearSecondary· Up to 1 year.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
1. \- No significant disability. Able to carry out all usual activities, despite some symptoms.
2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. \- Moderate disability. Requires some help, but able to walk unassisted.
4. \- Mode
Group
Value
95% CI
IV Rt-PA Cohort
70.9
69.3 – 72.5
Non-reperfusion Cohort
66.4
64.7 – 68.0
Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 YearSecondary· Up to 1 year.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
1. \- No significant disability. Able to carry out all usual activities, despite some symptoms.
2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. \- Moderate disability. Requires some help, but able to walk unassisted.
4. \- Mode
Group
Value
95% CI
IV Rt-PA Cohort
59.5
57.8 – 61.2
Non-reperfusion Cohort
54.6
52.8 – 56.3
Percentage of Patients With mRS Score 5 to 6 at 1 YearSecondary· Up to 1 year.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms.
1. \- No significant disability. Able to carry out all usual activities, despite some symptoms.
2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. \- Moderate disability. Requires some help, but able to walk unassisted.
4. \- Mode
Group
Value
95% CI
IV Rt-PA Cohort
15.9
14.6 – 17.2
Non-reperfusion Cohort
20.3
18.9 – 21.7
Distribution of mRS Score at 1 YearSecondary· Up to 1 year.
The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components.
The scale runs from 0-6, from 'perfect health without symptoms' to 'death'.
Group
Value
95% CI
IV Rt-PA Cohort
1.8
± 2.0
Non-reperfusion Cohort
2.0
± 2.1
Sponsor's own description
The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07519889 — Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Strok
· not yet recruiting
NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
· recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment
· NA
· recruiting
NCT07356011 — Exoskeleton for Balance
· NA
· recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in
· NA
· recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05395338.