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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Cardioembolic Stroke
• Intervention / Treatment: Drug: hirudin plus aspirin; Drug: Warfarin

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 Type: Observational
• Enrollment (Actual): 239

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome events	Intracranial hemorrhage and other bleeding events, any death and other serious adverse events	One year after stroke onset

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Xi'an Central Hospital; Shangluo Central Hospital; Baoji Central Hospital; Ankang Central Hospital; Yan'an University Affiliated Hospital; Hanzhong Central Hospital; Xiangyang Central Hospital; Yan'an people's Hospital; Shaanxi people's Hospital; The Third Hospital of PLA; Xianyang 215 hospital; Yulin Second Hospital; Baoji People's Hospital; 451 Hospital; Central Hospital of China Railway 20th Bureau; Xi'an Ninth Hospital; Shangluo Second People's Hospital
• Investigators: Study Chair: wen jiang, MD,PhD, The Department of Neurology , Xijing Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: atrial fibrillation; warfarin; aspirin; cardioembolic stroke; Hirudin
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Ischemic Stroke; Stroke; Atrial Fibrillation; Embolic Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Warfarin; Hirudins
• Other Study ID Numbers: Xijing-4-3