Validation of Predictors of OAC Initiation Using EMR Data

NCT03006341 | Completed Results FDA Drug

• 1 other identifier: 1160-0219
• Study Type: observational
• Target: 140,187
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are, first, to identify select clinical covariates from electronic medical records (EMR) that might be associated with initiation of oral anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial fibrillation (NVAF) at risk for stroke; second, to quantify the association between EMR-based clinical characteristics and patterns of insurance claims; third, to assess the potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies based on administrative claims databases.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (8)

• Percentage of Patients With Obesity

  Percentage of patients with obesity; where obesity is defined as "obese, not-obese based on note of obesity or recorded body mass index (BMI) \> 30 in the electronic medical records (EMR)". The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• Percentage of Patients Smoking

  Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• Percentage of Patients With Alcohol Consumption

  Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• Percentage of Patients With Abnormal Renal Function

  Percentage of patients with abnormal renal function; defined as "Any note of: Dialysis, renal transplant Serum Creatinine \>1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR)". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• Percentage of Patients With Bleeding History or Predisposition

  Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of \> 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)

  EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• EMR Characteristic: Serum Creatinine

  EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

• Percentage of Patients With Abnormal Liver Function

  Percentage of patients with abnormal liver function; defined as "Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) \>3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease". Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.

  Up to 12 months

Secondary Outcomes (10)

• EMR Characteristic: Duration of Atrial Fibrillation

  Up to 12 months

• EMR Characteristic: History of Adherence: Non-adherent/Adherent

  Up to 12 months

• EMR Characteristic: History/Duration of Hypertension

  Up to 12 months

• Percentage of Patients With Uncontrolled Hypertension

  Up to 12 months

• EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)

  Up to 12 months

Study Arms (2)

Dabigatran etexilate

NVAF patients initiating dabigatran etexilate

Drug: Dabigatran etexilate

Warfarin

NVAF patients initiating warfarin

Drug: Warfarin

Interventions

Dabigatran etexilate DRUG

observed upto 12 months

Also known as: MICARDIS, PRITOR, TELMISARTAN

Dabigatran etexilate

Warfarin DRUG

Observed upto 12 months

Warfarin

Eligibility Criteria

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

Study Population

Patients with a recorded diagnosis of atrial fibrillation without evidence of valvular etiology and at risk for stroke

You may qualify if:

• First dispensing of warfarin or dabigatran between October 2010 and December 2014
• Diagnosis of atrial fibrillation
• ≥ 12 months enrolment in the database preceding the date of the first dispensing
• Age ≥ 18
• Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease (CHA2DS2-VASc) score ≥ 1

You may not qualify if:

• Prior use of oral anticoagulation
• Evidence of valvular atrial fibrillation
• Missing or ambiguous age or sex information
• Patients with a nursing home stay during baseline

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Telmisartan; Warfarin

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; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 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

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: December 30, 2016
• Study Start: February 28, 2017
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-12

Locations

US (1)