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SNCTP000003662 | NCT04218266 | BASEC2019-02204

Klinische Studie über die Sicherheit und die Wirksamkeit des Medikaments BAY2433334 bei Patienten mit Vorhofflimmern

Data source: BASEC (Imported from 27.01.2022), WHO (Imported from 18.01.2022)
Changed: 18.01.2022
Disease category: Other

Brief description of trial (Data source: BASEC)

Das Ziel dieser Studie ist es, die beste Dosierung des neuen Medikaments BAY2433334 zu finden und zu untersuchen, wie gut es bei Patienten mit unregelmässigem Herzschlag (durch Vorhofflimmern) wirkt. Diese Krankheit kann Blutgerinnsel bewirken, auch Schlaganfälle oder andere Komplikationen im Herz-/ Kreislaufsystem. Das Studienmedikament wird betreffend seiner Sicherheit verglichen mit Apixaban, einem für diese Erkrankung zugelassenen anderen gerinnungshemmenden Medikament. Dieses Medikament verhindert Blutgerinnsel, die zu einem Schlaganfall führen können.

Health conditions investigated (Data source: BASEC)

Patienten mit Vorhofflimmern und mässigem bis hohem Risiko für Blutgerinnsel, die eine gerinnungshemmende Therapie benötigen

Health conditions (Data source: WHO)

Atrial Fibrillation (AF)

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Es gibt 4 Interventionen in dieser Studie:
-Bay2433334, das hier untersuchte Medikament als Tablette
-Apixaban Tabletten, die Vergleichsmedikation
-Placebo zu Bay2433334
-Placebo zu Apixaban

Alle Patienten erhalten eine Tablette mit Wirkstoff (entweder Bay2433334 oder Apixaban) und eine Placebotablette. Die Placebos sind nur nötig, um zu vermeiden, dass bekannt wird, ob der Patient Bay 2433334 oder Placebo erhält, da die verglichenen Medikamente unterschiedlich aussehen.

Interventions (Data source: WHO)

Drug: BAY2433334;Drug: Apixaban;Other: BAY2433334 matching placebo;Other: Apixaban matching placebo

Criteria for participation in trial (Data source: BASEC)

-Patienten ab 45 Jahren mit Vorhofflimmern, welches mit einem geschlechtsspezifischen Diagnoseverfahren (CHA2DS2-VASc score) diagnostiziert worden ist
-Indikation für gerinnungshemmende Therapie

Exclusion criteria (Data source: BASEC)

-Dem Patienten wurden mechanische Herzklappen eingesetzt
-Der Patient hat eine vorbestehende rheumatische Mitralklappenverengung oder eine mässige bis schwere nicht-rheumatische Mitralklappenstenose
-Patienten mit Vorhofflimmern, welches behandelt und beseitig werden kann (z.B. mit einer geplanten sog. "Ablation" oder mittels einem Medikament)

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Participant must be 45 years of age or older at the time of signing the informed
consent.

- Participant with AF documented by ECG evidence with

- CHA2DS2-VASc score = 2 if male or CHA2DS2-VASc score = 3 if female

- Indication for treatment with an oral anticoagulant in

- any participant currently not treated with an oral anticoagulant (e.g.
treatment naïve) or alternatively,

- participant on a NOAC in case of at least one bleeding risk feature (history
of a prior bleed within the last 12 months requiring medical attention and /
or moderate renal dysfunction with eGFR 30-50 ml/min and / or current
clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) =
100 mg)

- Written informed consent

Exclusion Criteria:

- Mechanical heart valve prosthesis

- Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral
stenosis

- Atrial fibrillation due to a reversible cause, participants in sinus rhythm after
successful ablation, or plan for cardioversion or ablation during study conduct

- Requirement for chronic anticoagulation (for a different indication than AF) or
antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic
therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)

- Treated with a Vitamin K antagonist in the 30 days prior to screening

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04218266

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04218266

Further information on trial

Date trial registered

02.01.2020

Incorporation of the first participant

30.01.2020

Recruitment status

Completed

Academic title (Data source: WHO)

Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Number of participants with composite of ISTH major and clinically relevant non-major bleeding

Secundary end point (Data source: WHO)

Number of participants with all bleeding;Number of participants with ISTH major bleeding;Number of participants with ISTH clinically relevant non-major bleeding;Number of participants with ISTH minor bleeding

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

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

Trial sites in Switzerland (Data source: BASEC)

Aarau, Basel, Bern, Geneva, Lugano, Luzern, St. Gallen, Winterthur

Countries (Data source: WHO)

Austria, Belgium, Canada, Czechia, France, Hungary, Italy, Japan, Latvia, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. Simon Rotzler
+41 44 465 81 11
clinical.operations.switzerland@bayer.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Bayer

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

12.02.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-02204

Secondary ID (Data source: WHO)

2019-002365-35
19765