Primary Objective:- to evaluate whether the oral FXIa inhibitor BAY 2433334 leads to a lower incidence of CV death, MI, stroke and stent thrombosis following an acute myocardial infarction when compared to a placebo- to evaluate whether the…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint: the composite of CV death, MI, stroke and stent
thrombosis
Primary Safety Endpoint: Bleeding Academic Research Consortium (BARC)
definition type 2, 3 and 5
Secondary outcome
Secondary Efficacy Endpoints:
- all cause mortality
- CV death
- MI
- stroke
- stent thrombosis
Secondary Safety Endpoints:
- all bleeding
- BARC bleeding definition type 3, 5
- BARC bleeding definition type 1, 2, 3, 5
Background summary
This study will explore a dose range of BAY 2433334 in order to determine the
dose that is efficacious and safe and that can be used in a Phase 3 study in
the same indication. Rivaroxaban in addition to single or dual antiplatelet
therapy (acetylsalicylic acid +/- clopidogrel) is the only non-Vitamin K oral
anticoagulants (NOAC) approved for secondary prevention of ACS in Europe. In
addition, the COMPASS study has also shown the benefit of this combination
(rivaroxaban in addition to acetylsalicylic acid) in patients with stable
coronary artery disease (CAD)/peripheral artery disease (PAD). The clinical use
of antiplatelet therapies together with an anticoagulant in acute coronary
syndrome (ACS) is limited due to concerns about bleeding risk. The inhibition
of FXIa on top of antiplatelet therapy is expected to not lead to a relevant
increase in bleeding and especially major bleeding, while maintaining the
efficacy benefit shown for the combination of antiplatelet therapies and
rivaroxaban.
Study objective
Primary Objective:
- to evaluate whether the oral FXIa inhibitor BAY 2433334 leads to a lower
incidence of CV death, MI, stroke and stent thrombosis following an acute
myocardial infarction when compared to a placebo
- to evaluate whether the incidence of bleeding is similar for BAY 2433334 and
placebo when treated on top of dual antiplatelet therapy
Study design
Multicenter, randomized, placebo controlled, double-blind, parallel group,
dose-finding phase 2 study to evaluate the efficacy and safety of BAY 2433334
in patients following an acute myocardial infarction
Intervention
3 investigational drug arms and 1 placebo arm:
- BAY 2433334 10 mg once daily
- BAY 2433334 20 mg once daily
- BAY 2433334 50 mg once daily
- Placebo once daily
The maximum duration of study participation is planned to be 55 weeks,
consisting of:
* Screening Period : * 5 days
* Treatment Period: between 26 and 52 weeks
* Safety Follow-up Period: 14 days
Study burden and risks
Visits;
Visits to the hospital between 4 and 7 times and telephone contact between 4
and 6 times. The number of hospital visits and telephone contact depends on the
number of weeks that the study duration for the patient (between 26 and 52
weeks). A visit to the hospital takes approximately 1 hour. There will be 1
visit with a duration of approximately 5 hours (visit 4, week 4).
Measurements:
Vital functions: Pulse rate, No risks, Every visit to the hospital.
Vital functions: Blood pressure, No risk: Possible discomfort around the arm
due to the blood pressure cuff, Every visit to the hospital.
Body weight and height: No risks, Visit 1.
Blood tests: Risks: Pain, Bruising, Weakness or dizziness, Infection. Every
visit to the hospital.
Electrocardiogram (ECG): Risk: Skin irritation, Visits 1, 2, 6 and 12.
BAY 2433334 may have a therapeutic benefit, but this cannot be guaranteed.
Patients have the risk of side effects.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
1. Participants must be 45 years of age or older, at the time of signing the
informed consent
2. Acute myocardial infarction (excluding MI associated with PCI or CABG
revascularization procedures) with:
a.clinical symptoms of acute myocardial infarction AND
b.elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain
isoenzyme [CK-MB] or cardiac troponins) AND
c.at least one of the following risk factors need to be fulfilled:
i. Age * 65 years
ii.Prior MI (before the index AMI event)
iii.Prior peripheral arterial disease
iv.Diabetes Mellitus
v.Prior coronary artery bypass grafting (CABG)
AND
d. initial angiography and revascularization procedures, either PCI or CABG,
as treatment for the index event performed before randomization. (Note: a
planned, staged PCI procedure can be performed after randomization)
3. Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital
discharge for the index AMI
4. Randomization during hospitalization for the index AMI event and latest
within 5 days of hospital admission
5. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in
this protocol. Written informed consent has to be signed before any
study-specific procedure.
Exclusion criteria
1. Hemodynamically significant ventricular arrhythmias or cardiogenic shock at
time of randomization
2. Active bleeding; known bleeding disorder, history of major bleeding
(intracranial, retroperitoneal, intraocular) or clinically significant
gastrointestinal bleeding within last 6 months of randomization
3. Planned use or requirement of full dose and long term anticoagulation
therapy during study conduct
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003244-79-NL |
| CCMO | NL72151.091.19 |