Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181361
• Other study ID #: Xijing-4-3
• Status: Completed
• Start date: June 2014
• Est. completion date: October 2018

Study information

• Verified date: September 2013
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardioembolic Stroke
• Stroke

Intervention

Drug:
• hirudin plus aspirin
natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily
• Warfarin
an initial dose of 1.25mg once daily. Three days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (18)

Lead Sponsor

Collaborator

Xijing Hospital

451 Hospital, Affiliated Hospital of Yan'an University, Ankang Central Hospital, Baoji Central Hospital, Baoji People's Hospital, Central Hospital of China Railway 20th Bureau, Hanzhong Central Hospital, Shaanxi people's Hospital, Shangluo Central Hospital, Shangluo Second People's Hospital, The Third Hospital of PLA, Xi'an Central Hospital, Xi'an Ninth Hospital, Xianyang 215 hospital, Xianyang Central Hospital, Yan'an people's Hospital, Yulin Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome events	Intracranial hemorrhage and other bleeding events, any death and other serious adverse events	One year after stroke onset
Primary	Efficacy outcome event: the recurrence of cardioembolic stroke	To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.	One year after stroke onset