GLORIA-AF Registry Program (Phase I)

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)

ClinicalTrials.gov ID

NCT01428765

Acronym / sponsor ID

1160.114

Conditions

Atrial Fibrillation

Study type

Observational

Recruitment status

Completed

Enrolment

1,096 participants (actual)

Lead sponsor

Boehringer IngelheimIndustry (pharma, biotech, devices)

Study start

May 2011

Primary completion

Jan 2013 (actual)

Study completion

Jan 2013 (actual)

First posted

5 Sep 2011 (estimated)

Results

Posted 5 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective

Cross-sectional

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

adult patients with non-valvular atrial fibrillation at risk for stroke

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. CHADS2 Score

   Time frame: 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%).

2. CHA2DS2-VASc Score

   Time frame: 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".

3. HAS-BLED Risk Score

   Time frame: 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.

4. Antithrombotic Treatment Choice at Baseline

   Time frame: Baseline

5. Gender

   Time frame: Baseline

6. Age Group

   Time frame: Baseline

7. Medical History

   Time frame: Baseline

8. Concomitant Medication

   Time frame: Baseline

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 24576516Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

Related trials for Atrial Fibrillation

• Active, not recruiting

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  Atrial Arrhythmia, Atrial Fibrillation

• RecruitingObservational study

  AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG

  Heart Failure, Atrial Fibrillation (AF)

• RecruitingObservational study

  Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

  Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia

• Not yet recruiting

  CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke

  Atrial Fibrillation (AF)

• Active, not recruiting

  ARIADNE Clinical Trial

  Persistent Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

62 sites in 8 countries: see every site and its status.