ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02181361
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : January 22, 2015
Sponsor:
Collaborators:
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
The Secondary Prevention of patients with an initial cardioembolic stroke associated with nonvalvular atrial fibrillation.

Condition or disease Intervention/treatment Phase
Cardioembolic Stroke Atrial Fibrillation Drug: aspirin plus hirudin Drug: Warfarin Phase 3

Detailed Description:
For the patients with stroke associated with atrial fibrillation,the guidelines recommend warfarin as the secondary prevention,but it's disadvantages such as the narrow safety scope,high bleeding risk hinder it's utilization in clinical.We divide our trial into two groups, the experimental group is aspirin plus Hirudin,the control group is warfarin.We aim at comparing two groups'efficacy and safety difference in secondary prevention of atrial fibrillation combined stroke.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Warfarin
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Other ischemic cerebrovascular disease [ Time Frame: one year after onset ]
    The occurrence of ischemic cerebrovascular disease except cardioembolic stroke


Other Outcome Measures:
  1. Safety [ Time Frame: one year after onset ]
    Intracranial hemorrhage and other bleeding events, any death and other serious adverse events causes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Stable condition within 14 days of oneset,Nonvalvular Atrial Fibrillation Patients With an Initial Cardioembolic Stroke
  • Diagnosis need to conform to the Cardioembolic Stroke about clinical and neuroimaging and laboratory examination requirements.

Exclusion Criteria:

  • Mitral stenosis or previous valvular heart surgery
  • Admission for acute coronary syndrome or percutaneous coronary intervention within 30 days
  • Active infective endocarditis
  • Purpura disease or blood coagulation disorder
  • Active bleeding or bleeding tendency
  • History of intracranial hemorrhage or other serious bleeding events
  • Confirmed with peptic ulcer disease within 30 days
  • Esophageal varices
  • Major surgical procedure or trauma in the previous 30 days
  • Persistent blood pressure 180/100 mm Hg or greater with or without antihypertensive treatment
  • Requirement for chronic anticoagulant treatment for disorders other than atrial fibrillation
  • Severe liver and kidney function
  • Allergy for warfarin, aspirin and hirudin
  • Child bearing potential, pregnancy, or lactation

Information from the National Library of Medicine

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


Contacts
Contact: wen jiang, MD 029-84771319 jiangwen@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Investigators
Study Chair: wen jiang, MD The Department of Neurology , Xijing Hospital

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02181361     History of Changes
Other Study ID Numbers: Xijing-4-3
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: September 2013

Keywords provided by Xijing Hospital:
atrial fibrillation
cardioembolic stroke
Hirudin
aspirin
warfarin

Additional relevant MeSH terms:
Aspirin
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Hirudins
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants