Trial Outcomes & Findings for Medical Need of OAC Reversal (NCT NCT03254147)

Last Updated: 2019-03-04

Results Overview

The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.

Recruitment status

COMPLETED

Target enrollment

53969 participants

Primary outcome timeframe

One year

Results posted on

2019-03-04

Participant Flow

Non-interventional study based on existing health insurance claims data

All patients were screened for eligibility to participate in the trial. Patients met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	Patients Prescribed With Non-warfarin Oral Anti Coagulants Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
Overall Study NOT COMPLETED	0
Overall Study STARTED	53969
Overall Study COMPLETED	53969

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Prescribed With Non-warfarin Oral Anti Coagulants n=53969 Participants Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
Age, Continuous	76 Years STANDARD_DEVIATION 10 • n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Sex: Female, Male Female	21587 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Sex: Female, Male Male	32382 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Ethnicity (NIH/OMB) Not Hispanic or Latino	53969 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) Asian	53969 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) White	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.

PRIMARY outcome

Timeframe: One year

Population: Results are based on the number of patients meeting the inclusion and exclusion criteria.

Outcome measures

Outcome measures
Measure	Patients Prescribed With Non-warfarin Oral Anti Coagulants n=53969 Participants Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. Age <=64	14 Number of Patients
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. Age 65-74	35 Number of Patients
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. Age >=75	84 Number of Patients

SECONDARY outcome

Timeframe: One year

Population: Results are based on the number of patients meeting the inclusion and exclusion criteria.

The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.

Outcome measures

Outcome measures
Measure	Patients Prescribed With Non-warfarin Oral Anti Coagulants n=53969 Participants Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.
The Number of Patients With Cardiac Tamponade and Pericardiocentesis.	1 Number of Patients

Adverse Events

Patients Prescribed With Non-warfarin Oral Anti Coagulants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER