Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

NCT03441633 | Completed Results DMC

• 2 other identifiers: B0661076SPAF
• Study Type: observational
• Target: 51,690
• Locations: 1 country
• Sites: 1

Brief Summary

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; apixaban; stroke

Outcome Measures

Primary Outcomes (14)

• Number of Participants by Their Sociodemographic Characteristics: Smoking Habit

  Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

  Day 1

• Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit

  Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.

  Day 1

• Number of Participants by Their Sociodemographic Characteristics: MEDEA

  Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.

  Day 1

• Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

  Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\^2).

  Day 1

• Number of Participants by Comorbidity

  Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.

  Up to 12 months after date of first prescription

• Risk of Bleeding Events: HAS-BLED Score

  Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \>3 = high risk of bleed per 100 participants-year.

  Up to 12 months prior to enrollment

• Risk of Thromboembolic Events: CHADS2 Score

  Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.

  Up to 12 months prior to enrollment

• Risk of Thromboembolic Events: CHA2DS2Vasc Score

  Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \>=65 and \<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.

  Up to 12 months prior to enrollment

• Number of Participants by Comedications

  Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.

  Up to 30 days after date of first prescription

• Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)

  MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \>120% of MPR.

  Up to 12 months after date of first prescription

• Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

  Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.

  Up to 12 months after date of first prescription

• Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

  NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.

  Up to 12 months after date of first prescription

• International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

  INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

  Up to 12 months after date of first prescription

• Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

  TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

  Up to 12 months after date of first prescription

Study Arms (4)

Group 1. Apixaban

Patients who are on treatment with apixaban. 1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 1b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: apixaban

Group 2. VKA

Patients who are on treatment with VKA. 2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 2b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: VKA

Group 3. Dabigatran

Patients who are on treatment with dabigatran. 3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 3b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: dabigatran

Group 4. Rivaroxaban

Patients who are on treatment with rivaroxaban. 4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 4b. patients who previously have been treated with VKA in the 12 months before index date.

Drug: rivaroxaban

Interventions

apixaban DRUG

current or new medication

Group 1. Apixaban

dabigatran DRUG

current or new medication

Group 3. Dabigatran

VKA DRUG

current or new medication

Group 2. VKA

rivaroxaban DRUG

current or new medication

Group 4. Rivaroxaban

Eligibility Criteria

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

Study Population

SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health. The study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.

You may qualify if:

• Patients more than 18 years-old.
• Patients diagnosed with NVAF registered in primary care according to ICD-10.
• Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
• Continuous enrolment in the 12 months pre-index.

You may not qualify if:

• Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
• Lost to follow-up (e.g. transfer to primary care center non-ICS).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Catalonia, 8007, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

apixaban; Dabigatran; Rivaroxaban

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: February 2, 2018
• First Posted: February 22, 2018
• Study Start: February 18, 2016
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: June 9, 2023
• Results First Posted: April 19, 2019

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)