A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke (PRISMS)
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|ClinicalTrials.gov Identifier: NCT02072226|
Recruitment Status : Terminated (The study was terminated due to slow enrollment.)
First Posted : February 26, 2014
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Alteplase Drug: Alteplase Placebo Drug: Aspirin Drug: Aspirin Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||313 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS)|
|Actual Study Start Date :||May 31, 2014|
|Actual Primary Completion Date :||March 22, 2017|
|Actual Study Completion Date :||March 22, 2017|
Active Comparator: Alteplase Placebo + Aspirin
Participants will receive single dose of IV alteplase placebo and aspirin orally.
Drug: Alteplase Placebo
Single dose of alteplase placebo will be administered as IV injection.Drug: Aspirin
Single dose of aspirin will be administered at 325 mg orally.
Experimental: Alteplase + Aspirin Placebo
Participants will receive single dose of IV alteplase and aspirin placebo orally.
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Other Name: Activase; RO5532960Drug: Aspirin Placebo
Single dose of aspirin placebo will be administered orally.
- Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 [ Time Frame: Day 90 ]
- Distribution of Participants Across the Ordinal mRS [ Time Frame: Day 90 ]
- Percentage of Participants With Global Favorable Recovery, as Calculated using the Global Outcome Measure Derived From the mRS, NIHSS, BI, and GOS [ Time Frame: Day 90 ]Global favorable recovery is an integrated assessment of participants who meet all of 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.
- Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH) [ Time Frame: Within 36 hours after study drug administration on Day 1 ]
- Percentage of Participants With Any ICH [ Time Frame: Within 36 hours after study drug administration on Day 1 ]
- Overall Mortality [ Time Frame: 90 days ]
- Percentage of Participants Who Died due to Stroke and Neurological Disorders [ Time Frame: 90 days ]
- Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072226
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|Study Director:||Clinical Trials||Genentech, Inc.|