Clinical trial NCT02181361: Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation
Official title: The Efficacy and Safety of Hirudin Plus Aspirin Versus Warfarin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardioembolic Stroke
Atrial Fibrillation
Keywords: atrial fibrillation
cardioembolic stroke
Hirudin
aspirin
warfarin
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Xi'an Central Hospital
name: Shaanxi people's Hospital
name: The Third Hospital of PLA
name: Hanzhong Central Hospital
name: Xianyang 215 hospital
name: Yulin Second Hospital
name: Yan'an University Affiliated Hospital
name: Baoji Central Hospital
name: Ankang Central Hospital
name: Baoji People's Hospital
name: Yan'an people's Hospital
name: 451 Hospital
name: Shangluo Central Hospital
name: Central Hospital of China Railway 20th Bureau
name: Xiangyang Central Hospital
name: Xi'an Ninth Hospital
name: Shangluo Second People's Hospital
First posted: 2014-07-03
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.

Brief summary: To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.

Detailed description: For the patients with cardioembolic stroke due to atrial fibrillation,guidelines recommended warfarin as the secondary prevention therapy. But warfarin has its disadvantages such as risk of bleeding and the requirement of frequent INR monitoring. The underuse of warfarin is a prominent problem in China. In our study, patients with cardioembolic stroke were treated with hirudin plus aspirin or warfarin. The aim of our study was to compare efficacy and safety of hirudin plus aspirin and warfarin in secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

1. age of 18 or older with NVAF-related cardioembolic stroke
2. diagnosis of cardioembolic stroke conformed to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification system in terms of the typical clinical presentation, neuroimaging profile, and vascular and cardiac evaluation
3. patients who were after 14 days of stroke onset and with stable clinical status.

Exclusion Criteria:

1. patients with rheumatic heart disease or history of heart valve surgery;
2. patients with acute coronary syndrome or percutaneous coronary intervention within 30 days previous to enrollment;
3. patients with active infective endocarditis;
4. patients with purpura disease or blood coagulation disorder;
5. patients who had active bleeding or the tendency to bleed;
6. patients with history of intracranial hemorrhage (ICH) or other serious bleeding events;
7. patients diagnosed with peptic ulcer disease within 30 days previous to enrollment;
8. patients who had esophageal varices;
9. patients who had trauma or major surgery within 30 days previous to enrollment or patients who planned to have major surgery;
10. patients with persistent blood pressure of 180/100mmHg or greater with or without anti-hypertension treatment;
11. patients who need chronic anticoagulant treatment due to disorders other than AF;
12. patients with severe liver and kidney dysfunction;
13. patients who were allergic to warfarin, aspirin or hirudin;
14. female patients who are pregnant or lactating.

Primary outcomes:
measure: Efficacy outcome event: the recurrence of cardioembolic stroke
timeFrame: One year after stroke onset
Secondary outcomes:
Other outcomes:
measure: Safety outcome events
timeFrame: One year after stroke onset
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: The Department of Neurology , Xijing Hospital
name: wen jiang, MD,PhD
role: STUDY_CHAIR
References: