Trial Outcomes & Findings for GLORIA-AF Registry Program (Phase I) (NCT NCT01428765)

Results Overview

CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).

Recruitment status

COMPLETED

Target enrollment

1096 participants

Primary outcome timeframe

Baseline

Results posted on

2014-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients
Overall Study STARTED	1063
Overall Study COMPLETED	1063
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GLORIA-AF Registry Program (Phase I)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=1063 Participants
Age, Continuous	68.2 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	486 Participants n=5 Participants
Sex: Female, Male Male	577 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
CHADS2 Score Low (Score=0)	102 participants
CHADS2 Score Moderate (Score=1)	386 participants
CHADS2 Score High (Score >=2)	575 participants

PRIMARY outcome

Timeframe: Baseline

The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to "low risk", a score of 1 corresponds to "intermediate risk", and a score of 2 or more corresponds to "high risk".

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
CHA2DS2-VASc Score Low (Score=0)	0 participants
CHA2DS2-VASc Score Moderate (Score=1)	226 participants
CHA2DS2-VASc Score High (Score >=2)	837 participants

PRIMARY outcome

Timeframe: Baseline

The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure \>160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age \>65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
HAS-BLED Risk Score Low (Score <3)	860 participants
HAS-BLED Risk Score High (Score >=3)	121 participants
HAS-BLED Risk Score Missing	82 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
Antithrombotic Treatment Choice at Baseline None	215 participants
Antithrombotic Treatment Choice at Baseline Vitamin K Antagonist (VKA)	349 participants
Antithrombotic Treatment Choice at Baseline Acetylsalicylic Acid (ASA)	443 participants
Antithrombotic Treatment Choice at Baseline Antiplatelet agents other than ASA	36 participants
Antithrombotic Treatment Choice at Baseline Other	20 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
Gender Female	486 participants
Gender Male	577 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
Age Group <65 years	382 participants
Age Group 65 to <75 years	314 participants
Age Group >= 75 years	367 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
Medical History Previous stroke	110 participants
Medical History Coronary artery disease (CAD)	256 participants
Medical History Congestive heart failure	256 participants
Medical History History of hypertension	795 participants
Medical History Diabetes mellitus	240 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	All Patients n=1063 Participants
Concomitant Medication Antihypertensive/heart failure and antiarrhythmic	739 participants
Concomitant Medication Metabolic and anti-inflammatory therapy	395 participants

Adverse Events

All Patients

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 Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER