Trial Outcomes & Findings for TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion (NCT NCT01654445)
NCT ID: NCT01654445
Last Updated: 2020-11-25
Results Overview
The primary safety outcome will be the rate of expected serious adverse events associated with study drug. This will be defined as the number patients with at least one SAE divided by the number of patients enrolled by dose-tier. Thus, the unit of analysis will be the patient and not the SAE.
COMPLETED
PHASE2
50 participants
Up to 12 weeks
2020-11-25
Participant Flow
Patients were recruited from July 2012 through July 2014
All patients were treated with study drug.
Participant milestones
| Measure |
Tenecteplase 0.1 mg/kg
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion
Baseline characteristics by cohort
| Measure |
Tenecteplase 0.1 mg/kg
n=25 Participants
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=25 Participants
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Continuous
|
72 years
n=99 Participants
|
71 years
n=107 Participants
|
71 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: All participants
The primary safety outcome will be the rate of expected serious adverse events associated with study drug. This will be defined as the number patients with at least one SAE divided by the number of patients enrolled by dose-tier. Thus, the unit of analysis will be the patient and not the SAE.
Outcome measures
| Measure |
Tenecteplase 0.1 mg/kg
n=25 Participants
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=25 Participants
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Number of Patients With Serious Bleeding Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All enrolled participants
Complete neurological and functional recovery at 90 days defined as: NIHSS 0 and mRS 0 iii)Complete neurological and functional recovery at 90 days defined as: a. NIHSS 0-1 and mRS 0-1 and Barthel Index \> 90 NIHSS = National Institutes of Health Stroke Scale. This integer scale ranges 0-42 and is a quantitative measure of the neurological examination. mRS = modified Rankin Scale. This integer scale ranges from 0-6 and is a criterion-based quantitative measure of functional neurological disability. BI = Barthel Index. This scale range from 0-100 (in increments of 5 points) and is a summative categorical score measuring activities of daily living.
Outcome measures
| Measure |
Tenecteplase 0.1 mg/kg
n=25 Participants
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=25 Participants
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90
NIHSS = 0 at 90d
|
15 Participants
|
19 Participants
|
|
Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90
mRS = 0 at 90d
|
10 Participants
|
14 Participants
|
|
Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90
Barthel Index > 90 at 90d
|
22 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-8 hoursPopulation: 2 patients in each tier had missing data on this outcome.
Recanalization defined on follow-up 4-8 hour CTA as a modified arterial occlusive lesion (mAOL) score 0-1.
Outcome measures
| Measure |
Tenecteplase 0.1 mg/kg
n=23 Participants
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=23 Participants
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Number of Patients With Recanalization 4-8 Hours Post-treatment
|
9 Participants
|
12 Participants
|
Adverse Events
Tenecteplase 0.1 mg/kg
Tenecteplase 0.25 mg/kg
Serious adverse events
| Measure |
Tenecteplase 0.1 mg/kg
n=25 participants at risk
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=25 participants at risk
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Nervous system disorders
symptomatic intracerebral hemorrhage
|
0.00%
0/25 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
4.0%
1/25 • Number of events 1 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
Other adverse events
| Measure |
Tenecteplase 0.1 mg/kg
n=25 participants at risk
25 patients treated with 0.1 mg/kg intravenous tenecteplase
|
Tenecteplase 0.25 mg/kg
n=25 participants at risk
25 patients treated with 0.25 mg/kg intravenous tenecteplase
|
|---|---|---|
|
Nervous system disorders
Asymptomatic intracerebral hemorrhage
|
4.0%
1/25 • Number of events 1 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
4.0%
1/25 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
|
Cardiac disorders
Atrial fibrillation
|
12.0%
3/25 • Number of events 3 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
0.00%
0/25 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Number of events 5 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
12.0%
3/25 • Number of events 3 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
|
Vascular disorders
Carotid revascluarization (CEA or CAS)
|
8.0%
2/25 • Number of events 2 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
0.00%
0/25 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
|
Renal and urinary disorders
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
8.0%
2/25 • Number of events 2 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
|
Skin and subcutaneous tissue disorders
Bruising/hematoma
|
0.00%
0/25 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
8.0%
2/25 • Number of events 2 • 90 days from the date of enrolment
Symptomatic intracranial hemorrhage
|
Additional Information
Shelagh B Coutts and Michael D Hill
University of Calgary, Department of Clinical Neurosciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place