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

Browse trials for

• Atrial Fibrillation 3,957
• Stroke 7,441

Keywords

• atrial fibrillation
• apixaban
• stroke

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 51,690 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Study population

Groups and cohorts

• 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

• Drugapixaban

  current or new medication

• Drugdabigatran

  current or new medication

• DrugVKA

  current or new medication

• Drugrivaroxaban

  current or new medication

Primary outcomes

1. 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.

   Time frame: Day 1

2. 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.

   Time frame: Day 1

3. 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.

   Time frame: Day 1

4. 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).

   Time frame: Day 1

5. 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.

   Time frame: Up to 12 months after date of first prescription

6. 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.

   Time frame: Up to 12 months prior to enrollment

7. 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.

   Time frame: Up to 12 months prior to enrollment

8. 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.

   Time frame: Up to 12 months prior to enrollment

9. Number of Participants by Comedications

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

   Time frame: Up to 30 days after date of first prescription

10. 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.

    Time frame: Up to 12 months after date of first prescription

11. 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.

    Time frame: Up to 12 months after date of first prescription

12. 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.

    Time frame: Up to 12 months after date of first prescription

13. 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).

    Time frame: Up to 12 months after date of first prescription

14. 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).

    Time frame: Up to 12 months after date of first prescription

Baseline characteristics

Related links

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

Study documents

• Protocol and statistical analysis plan · Nov 7, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.