Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258645
Recruitment Status : Completed
First Posted : August 23, 2017
Results First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
SITS international registry, Karolinska University Hospital, Stockholm, Sweden
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.

The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.


Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Dabigatran

Layout table for study information
Study Type : Observational
Actual Enrollment : 1489 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A Retrospective Analysis From the SITS-AF Registry on Treatment Initiation of Dabigatran Etexilate in Non-valvular Atrial Fibrillation Patients Hospitalized With Acute Ischemic Stroke
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019


Group/Cohort Intervention/treatment
Acute ischemic stroke
Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke
Drug: Dabigatran
Oral anticoagulant (NOAC) thrombin inhibitor
Other Name: Pradaxa




Primary Outcome Measures :
  1. Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) [ Time Frame: Up to 3 months of follow-up after index event ]
    To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.


Secondary Outcome Measures :
  1. National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event) date, up to 1 day. ]
    The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.

  2. Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event) date, up to 1 day. ]
    Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.

  3. Age of Patients According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (>65 years), Drugs and Alcohol Score.

  4. Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.

  5. CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.

  6. HAS-BLED of Patients According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.

  7. Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.

  8. Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. [ Time Frame: Up to 3 months of follow-up after index event. ]
    Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

  9. Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period [ Time Frame: At first ever ischaemic stroke (index event), up to 1 day. ]
    Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

  10. Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians [ Time Frame: Up to 3 months of follow-up after index event. ]
    Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.

  11. Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians [ Time Frame: Up to 3 months of follow-up after index event. ]
    Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000
Criteria

Inclusion criteria:

  • Patients with non-valvular Atrial Fibrillation (NVAF)
  • Patients presenting with their first acute ischemic stroke
  • ≥18 years of age

Exclusion criteria:

- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the duration of the data collection


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258645


Locations
Layout table for location information
Sweden
SITS International (c/o Karolinska University Hospital)
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Boehringer Ingelheim
SITS international registry, Karolinska University Hospital, Stockholm, Sweden
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] July 5, 2017
Statistical Analysis Plan  [PDF] November 7, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03258645    
Other Study ID Numbers: 1160.235
First Posted: August 23, 2017    Key Record Dates
Results First Posted: July 9, 2020
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants