The Secondary Prevention of Nonvalvular Atrial Fibrillation Patients With an Initial Cardioembolic Stroke (CE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02181361|
Recruitment Status : Unknown
Verified September 2013 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : July 3, 2014
Last Update Posted : January 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardioembolic Stroke Atrial Fibrillation||Drug: aspirin plus hirudin Drug: Warfarin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness and Safety of Aspirin Plus Hirudin in the Secondary Prevention of Cardioembolic Stroke|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||October 2018|
Experimental: aspirin plus hirudin
14 days after stroke occurred, the experimental group gives hirudin two tables three times a day and aspirin 100mg, once daily.
Drug: aspirin plus hirudin
hirudin two tables, three times a day and aspirin 100mg, once daily.
Active Comparator: Warfarin
14 days after stroke occurred,the control group gives an initial dose of 1.5mg,once daily. 3 days later,we check the international normalized ratio(INR) values and adjust the warfarin dose make INR between 2-3 steady.Then, we maintain this warfarin dose.
An initial dose of Warfarin is 1.5mg,once daily. 3 days later,we check the international normalized ratio(INR) values and adjust the warfarin dose make INR between 2-3 steady.Then, we maintain this warfarin dose.
- The recurrence of cardioembolic stroke [ Time Frame: up to one year after onset ]compare the recurrence rates of the experimental group with the control group
- Other ischemic cerebrovascular disease [ Time Frame: one year after onset ]The occurrence of ischemic cerebrovascular disease except cardioembolic stroke
- Safety [ Time Frame: one year after onset ]Intracranial hemorrhage and other bleeding events, any death and other serious adverse events causes
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): NCT02181361
|Contact: wen jiang, MDemail@example.com|
|Xi'an, Shaanxi, China, 710032|
|Study Chair:||wen jiang, MD||The Department of Neurology , Xijing Hospital|