Trial Outcomes & Findings for A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke (NCT NCT02072226)
NCT ID: NCT02072226
Last Updated: 2018-07-03
Results Overview
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
313 participants
Primary outcome timeframe
Day 90
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Alteplase + Aspirin Placebo
Participants received single dose of 0.9 milligram per kilogram (mg/kg) (maximal dose of 90 mg) intravenous (IV) alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
157
|
|
Overall Study
COMPLETED
|
141
|
147
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Alteplase + Aspirin Placebo
Participants received single dose of 0.9 milligram per kilogram (mg/kg) (maximal dose of 90 mg) intravenous (IV) alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
7
|
|
Overall Study
Patient Non-compliance
|
2
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Patient Withdrawal of Consent
|
1
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
Baseline characteristics by cohort
| Measure |
Alteplase + Aspirin Placebo
n=156 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=157 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.94 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
61.20 years
STANDARD_DEVIATION 13.05 • n=7 Participants
|
61.57 years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Total National Institutes of Health Stroke Scale (NIHSS)
|
2.3 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.15 • n=7 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Intent-to-Treat (ITT) population included all randomized participants.
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=156 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=157 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90
|
78.2 percentage of participants
|
81.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: ITT population included all randomized participants.
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=156 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=157 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 0
|
44.9 percentage of participants
|
50.3 percentage of participants
|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 1
|
33.3 percentage of participants
|
31.2 percentage of participants
|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 2
|
11.5 percentage of participants
|
11.5 percentage of participants
|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 3
|
2.6 percentage of participants
|
3.2 percentage of participants
|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 4
|
5.1 percentage of participants
|
2.5 percentage of participants
|
|
Distribution of Participants Across the Ordinal mRS
mRS at Day 90 - 5 or 6 (death)
|
2.6 percentage of participants
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 90Population: ITT population included all randomized participants.
Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index \[BI\] greater than or equal to 95, and Glasgow Outcome Scale \[GOS\] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=156 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=157 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
mRS 0 - 1 at Day 90
|
78.2 percentage of participants
|
81.5 percentage of participants
|
|
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
NIHSS 0 - 1 at Day 90
|
85.0 percentage of participants
|
81.7 percentage of participants
|
|
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
BI >= 95 at Day 90
|
79.3 percentage of participants
|
88.7 percentage of participants
|
|
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
GOS = 1 at Day 90
|
81.5 percentage of participants
|
85.6 percentage of participants
|
SECONDARY outcome
Timeframe: Within 36 hours after study drug administration on Day 1Population: Safety Population included all participants, who received any amount of study drug.
ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
|
3.2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 36 hours after study drug administration on Day 1Population: Safety Population included all participants, who received any amount of study drug.
To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With Any ICH
Any ICH within 36 hours reported by site
|
7.1 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Any ICH
Any ICH within 36 hours reported by central reader
|
7.1 percentage of participants
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Day 90Population: Safety Population included all participants, who received any amount of study drug.
Reported here is the percentage of participants who died due to any cause during the study.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Overall Mortality
|
0.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Day 90Population: Safety Population included all participants, who received any amount of study drug.
Reported here is the percentage of participants who died due to stroke and neurological disorders.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants Who Died Due to Stroke and Neurological Disorders
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.Population: Safety Population included all participants, who received any amount of study drug.
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
77.3 percentage of participants
|
68.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to Day 90Population: Safety Population included all participants, who received any amount of study drug.
A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Outcome measures
| Measure |
Alteplase + Aspirin Placebo
n=154 Participants
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 Participants
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events
|
26.0 percentage of participants
|
13.1 percentage of participants
|
Adverse Events
Alteplase + Aspirin Placebo
Serious events: 40 serious events
Other events: 49 other events
Deaths: 1 deaths
Alteplase Placebo + Aspirin
Serious events: 20 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alteplase + Aspirin Placebo
n=154 participants at risk
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 participants at risk
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Eye disorders
Vitreous haemorrhage
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Volvulus
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
General disorders
Gait disturbance
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
3.2%
5/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
1.3%
2/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Stroke in evolution
|
3.2%
5/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Seizure
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
1.3%
2/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
2.0%
3/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
1.3%
2/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.3%
2/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Sciatica
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Product Issues
Device loosening
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Renal and urinary disorders
Renal embolism
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.65%
1/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.65%
1/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
0.00%
0/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
Other adverse events
| Measure |
Alteplase + Aspirin Placebo
n=154 participants at risk
Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
|
Alteplase Placebo + Aspirin
n=153 participants at risk
Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.8%
9/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
8.5%
13/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.2%
8/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
6.5%
10/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.5%
7/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
7.8%
12/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
9/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
5.9%
9/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
16.2%
25/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
17.0%
26/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
7.1%
11/154 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
6.5%
10/153 • Serious adverse events were collected from baseline through the end of study at Day 90. Non-serious adverse events were collected from baseline through the Day 30 visit.
Safety population included all participants, who received any amount of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER