Display again
EUCTR2019-002075-33

Reduction in the risk of stroke in people who have both a previous intracranial bleed and atrial fibrillation

Data source: WHO (Imported from 18.10.2020)
Changed: 18.10.2020
Disease category:

Health conditions (Data source: WHO)

High risk atrial fibrillation patients with previous intracranial hemorrhage
MedDRA version: 21.1Level: PTClassification code 10018985Term: Haemorrhage intracranialSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Interventions (Data source: WHO)


Trade Name: Lixiana
Product Name: Edoxaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Edoxaban
CAS Number: 480449-71-6
Other descriptive name: EDOXABAN TOSYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Trade Name: Lixiana
Product Name: Edoxaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Edoxaban
CAS Number: 480449-71-6
Other descriptive name: EDOXABAN TOSYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
1.Written informed consent provided
2.Age =45 years, at the time of signing the informed consent
3.Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic intraparenchymal, intraventricular, and/or cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
4.Documented atrial fibrillation (paroxysmal, persistent, permanent)
5.CHA2DS2-VASc score =2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960

Exclusion criteria:
1.Recent intracranial hemorrhage (within 14 days)
2.Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
3.Traumatic or aneurysmal cSAH
4.Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
5.Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
6.Plans for left atrial appendage occlusion
7.Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)
8.Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
9.Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
10.Chronic use of NSAID
11.Clinically significant active bleeding, including gastrointestinal bleeding
12.Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
13.Antiphospholipid antibody syndrome
14.Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
15.Known hypersensitivity to edoxaban
16.Estimated inability to adhere to study procedures
17.Pregnancy or breastfeeding
18.Estimated life expectancy < 6 months at the time of enrollment
19.Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site)

* Post menopausal female subjects must be amenorrheic for =12 months prior to screening or =6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002075-33

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2019-002075-33-DE

Further information on trial

Date trial registered

18.09.2019

Incorporation of the first participant

06.10.2020

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

Edoxaban for intracranial hemorrhage survivors with atrial fibrillation - ENRICH-AF: EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): yes

Primary end point (Data source: WHO)

Main Objective: To determine whether edoxaban (60/30 mg daily) compared to non-anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc score =2) patients with previous intracranial hemorrhage.;Secondary Objective: i) To assess whether edoxaban (60/30 mg daily) compared to non-anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of cardiovascular death in high-risk atrial fibrillation participants with previous intracranial hemorrhage.

ii) To assess whether edoxaban (60/30 mg daily) is associated with increased risk of major hemorrhage compared to standard of care (either no antithrombotic therapy or antiplatelet monotherapy).
;Primary end point(s): The primary efficacy end point is stroke (composite of ischemic, hemorrhagic and unspecified).

The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria

;Timepoint(s) of evaluation of this end point: Participants will be followed every 6 months until the common study end date. This trial is event driven to accrue 123 primary events, anticipated one year after the end of the recruitment. Follow up is anticipated to be an average of 24 months per participant (range 1 to 3 years).

Secundary end point (Data source: WHO)

Secondary end point(s): The secondary efficacy end points are:
1.Ischemic stroke
2.Cardiovascular death
3.Hemorrhagic stroke
4.Disabling/fatal stroke
5.Composite of all stroke, myocardial infarction, systemic thromboembolism or all-cause death
6.Net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)
7.Modified Rankin scale (mRS) at 12 months

The secondary safety end point(s) are:
1.All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
2.Fatal intracranial hemorrhage
3.Subdural hemorrhage
4.Hospitalization for any cause
;Timepoint(s) of evaluation of this end point: Timepoints of evaluation will be every 6 months until the common study end date. Follow up is anticipated to be an average of 24 months per participant (range 1 to 3 years).

Contact information (Data source: WHO)

Daiichi Sankyo

Trial results (Data source: WHO)

Results summary

Edoxaban for intracranial hemorrhage survivors with atrial fibrillation

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Argentina, Austria, Belgium, Canada, China, Czech Republic, Egypt, Germany, Greece, India, Italy, Korea, Nepal, Norway, Poland, Portugal, Republic of, Slovakia, Spain, Switzerland, Taiwan, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

ENRICH-AF Research Coordinator
237 Barton Street East
Hamilton Health Sciences, through its Population Health Research Institute
1905527-4322
ENRICH-AF@phri.ca

Contact for scientific information (Data source: WHO)

ENRICH-AF Research Coordinator
237 Barton Street East
Hamilton Health Sciences, through its Population Health Research Institute
1905527-4322
ENRICH-AF@phri.ca

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Hamilton Health Sciences, through its Population Health Research Institute

Further trial identification numbers

Secondary ID (Data source: WHO)

ENRICH-AF
NCT03950076
2019-002075-33-GB