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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258645
• Other study ID #: 1160.235
• Status: Completed
• Start date: November 15, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: July 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1489
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dabigatran
Oral anticoagulant (NOAC) thrombin inhibitor

Locations

Country	Name	City	State
Sweden	SITS International (c/o Karolinska University Hospital)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	SITS international registry, Karolinska University Hospital, Stockholm, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Up to 3 months of follow-up after index event
Secondary	National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event) date, up to 1 day.
Secondary	Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event) date, up to 1 day.
Secondary	Age of Patients According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period	Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	HAS-BLED of Patients According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.	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.	Up to 3 months of follow-up after index event.
Secondary	Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period	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.	At first ever ischaemic stroke (index event), up to 1 day.
Secondary	Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians	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.	Up to 3 months of follow-up after index event.
Secondary	Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians	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.	Up to 3 months of follow-up after index event.

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