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NCT Number: NCT02181361

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of 18 or older with NVAF-related cardioembolic stroke
  • 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
  • patients who were after 14 days of stroke onset and with stable clinical status.

Exclusion criteria

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

Treatment and study plan

hirudin plus aspirin

Drug

natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily

Warfarin

Drug

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.

Primary outcomes

  1. Efficacy outcome event: the recurrence of cardioembolic stroke

    Time frame: One year after stroke onset

    To compare the recurrence of cardioembolic stroke in hirudin plus aspirin group and the warfarin group.

Other outcomes

  1. Safety outcome events

    Time frame: One year after stroke onset

    Intracranial hemorrhage and other bleeding events, any death and other serious adverse events

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jul 3, 2014
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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