NCT03285373 (RE-CONOCE) is a clinical trial of NOAC in Atrial Fibrillation, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03285373?

NCT03285373 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03285373?

Interventions in NCT03285373: NOAC.

What condition does NCT03285373 study?

NCT03285373 studies Atrial Fibrillation.

Is NCT03285373 still recruiting?

NCT03285373 is currently completed. Last updated 18 February 2020.

Are results published for NCT03285373?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-02-18 · How we verify

NCT03285373: RE-CONOCE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain

Completed Results posted Last updated 18 February 2020

What this trial tests

trial testing NOAC in Atrial Fibrillation in 1,008 participants. Completed in 31 January 2019.

Timeline

29 November 2017

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,008
Start date	29 November 2017
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	75 locations across Spain

Drugs / interventions tested

NOAC — full drug profile →

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation Primary · Start of the first NOAC treatment

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.

Group	Value	95% CI
Dabigatran	72.8	± 9.9
Rivaroxaban	72.5	± 10.7
Apixaban	72.6	± 9.8
Edoxaban	74.0	± 10.0
All Patients	72.8	± 10.1

Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation Primary · Start of the first NOAC treatment

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a

Group	Value	95% CI
Dabigatran	3.2	± 1.5
Rivaroxaban	3.3	± 1.6
Apixaban	3.3	± 1.5
Edoxaban	3.3	± 1.5
All Patients	3.3	± 1.5

Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation Primary · Start of the first NOAC treatment

Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female)

Low risk

Group	Value	95% CI
Dabigatran	3
Rivaroxaban	10
Apixaban	3
Edoxaban	0
All Patients	16

Moderate risk

Group	Value	95% CI
Dabigatran	53
Rivaroxaban	34
Apixaban	36
Edoxaban	21
All Patients	144

High risk

Group	Value	95% CI
Dabigatran	252
Rivaroxaban	207
Apixaban	215
Edoxaban	108
All Patients	782

Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation Primary · Start of the first NOAC treatment

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.

Group	Value	95% CI
Dabigatran	1.8	± 1.0
Rivaroxaban	1.8	± 1.1
Apixaban	1.7	± 1.1
Edoxaban	1.8	± 1.0
All Patients	1.8	± 1.1

Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation Primary · Start of the first NOAC treatment

Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3)

Low risk

Group	Value	95% CI
Dabigatran	17
Rivaroxaban	29
Apixaban	27
Edoxaban	11
All Patients	84

Moderate risk

Group	Value	95% CI
Dabigatran	219
Rivaroxaban	157
Apixaban	170
Edoxaban	86
All Patients	632

High risk

Group	Value	95% CI
Dabigatran	72
Rivaroxaban	65
Apixaban	56
Edoxaban	31
All Patients	224

Appropriateness of NOACs Prescription Secondary · single visit (Day 1)

Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA trea

Group	Value	95% CI
All Patients	88
All Patients	10
All Patients	16
All Patients	16

Mean Number of Visits to the Physician Per Year Secondary · 1 year (data collected during single visit on day 1)

Mean number of visits to the physician per year considered for the NOAC Management.

Group	Value	95% CI
All Patients	2.0	± 1.1

Duration of First NOAC, All NOAC and Subsequent NOAC Treatment Secondary · Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.

Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).

First NOAC

Group	Value	95% CI
All Patients	9.4	± 6.5

All NOAC

Group	Value	95% CI
All Patients	9.6	± 6.5

Subsequent NOAC

Group	Value	95% CI
All Patients	5.1	± 4.1

Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC Secondary · single visit (Day 1)

Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC

Discontinue treatment

Group	Value	95% CI
All Patients	4

Dose adjustment

Group	Value	95% CI
All Patients	20

Change to a new NOAC

Group	Value	95% CI
All Patients	32

No change

Group	Value	95% CI
All Patients	907

Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Secondary · single visit (Day 1)

Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.

Group	Value	95% CI
All Patients	5
All Patients	4
All Patients	1
All Patients	2

Reason for Treatment Changes Secondary · Start of the first NOAC treatment

Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.

Lack of efficacy

Group	Value	95% CI
All Patients	5

Investigator decision

Group	Value	95% CI
All Patients	30

Patient decision

Group	Value	95% CI
All Patients	7

Adverse event

Group	Value	95% CI
All Patients	14

Number of Patients With Previous Treatment With Vitamin K Antagonists Secondary · single visit (Day 1)

Number of patient with Previous Treatment with Vitamin K Antagonists.

Group	Value	95% CI
Dabigatran	146
Rivaroxaban	125
Apixaban	100
Edoxaban	53
All Patients	424
Dabigatran	168
Rivaroxaban	128
Apixaban	166
Edoxaban	77
All Patients	539

Adverse events — posted to ClinicalTrials.gov

Time frame: From Informed consent signed until the end of the trial, up to 12 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dabigatran

Serious: 3/314 (1%)

Deaths: 1/314

Serious adverse events (3 terms)

Reaction	System	Dabigatran
Sudden death	General disorders	—
Ischaemic stroke	Nervous system disorders	—
Cerebrovascular disorder	Nervous system disorders	—

Most-reported serious reactions: Sudden death, Ischaemic stroke, Cerebrovascular disorder.

Data from ClinicalTrials.gov NCT03285373 adverse events section.

Sponsor's own description

The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of NOAC

Trials testing the same drug.

NCT06212674 — Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients · Phase 4 · recruiting
NCT03642509 — Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation · NA · recruiting
NCT03284827 — Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transca · Phase 4 · completed
NCT03362788 — The Greek AntiPlatElet Atrial Fibrillation Registry. · completed
NCT02998905 — NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH · Phase 2 · completed

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03285373 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 18 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03285373.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing