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

Completed

• Conditions: Cardioembolic Stroke; Atrial Fibrillation
• Interventions: Drug: hirudin plus aspirin; Drug: Warfarin

• Registration Number: NCT02181361
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2013-09
• Study Start: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2016-12
• Study Completion: 2018-10
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hirudin plus aspirin	hirudin plus aspirin	14 days after stroke onset, patients in the hirudin plus aspirin group received natural hirudin 0.75g, three times a day and aspirin 100mg, once daily.
Warfarin	Warfarin	14 days after stroke onset, patients in warfarin group were given an initial dose of 1.25mg of warfarin,once daily. 3 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.

Primary Outcome Measures

Name	Time	Method
Efficacy outcome event: the recurrence of cardioembolic stroke	One year after stroke onset	To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China