A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke (PRISMS)
|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|
|Primary Completion Date :||March 22, 2017|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072226
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|Study Director:||Clinical Trials||Genentech, Inc.|