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

NCT02181361 | Completed DMC

• 1 other identifier: Xijing-4-3
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardioembolic Stroke; Atrial Fibrillation

Keywords

atrial fibrillation; cardioembolic stroke; Hirudin; aspirin; warfarin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety outcome events

  One year after stroke onset

Study Arms (2)

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

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

Interventions

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

hirudin plus aspirin

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.

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardioembolic stroke patients due to nonvalvular atrialf ibrillation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Embolic Stroke; Atrial Fibrillation

Interventions

Hirudins; Aspirin; Warfarin

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• wen jiang, MD,PhD

  The Department of Neurology , Xijing Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: July 3, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2018
• Last Updated: April 21, 2020

Record last verified: 2013-09

Locations

CN (1)