Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

NCT02240667 | Completed Results

• 1 other identifier: 1160.218
• Study Type: observational
• Target: 1,506
• Locations: 1 country
• Sites: 1

Brief Summary

1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month

  Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.

  12 month (Visit 5)

Secondary Outcomes (2)

• Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.

  6 month (visit 3)

• Number of Patients With the Reason for Definitive Treatment Discontinuation

  Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)

Study Arms (1)

Subjects with atrial fibrillation

Drug: Dabigatran etexilate; Drug: Vitamin K antagonists

Interventions

Dabigatran etexilate DRUG

150 mg or 110 mg capsules twice daily

Subjects with atrial fibrillation

Vitamin K antagonists DRUG

International Normalized Ratio (INR) 2-3

Also known as: Phenprocoumon

Subjects with atrial fibrillation

Eligibility Criteria

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

Study Population

AF patients

You may qualify if:

• Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).
• Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.
• Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)

You may not qualify if:

• Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.
• Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.
• Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.
• Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; acarboxyprothrombin; Phenprocoumon

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 16, 2014
• Study Start: September 18, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-04

Locations

DE (1)