20603 Phase 2 Program of AntiCoagulation via Inhibition of FX1a
Research type
Research Study
Full title
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
IRAS ID
1003070
Contact name
Vijay Kunadian
Contact email
Eudract number
2019-003244-79
Clinicaltrials.gov Identifier
Research summary
Research Summary
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Summary of Results
Did BAY 2433334 help to reduce the number of participants who experienced another heart attack, a stroke, stent thrombosis, or dying from an event related to the heart or blood vessels?
No. Overall, the researchers found that BAY 2433334 did not help to reduce the number of participants who experienced another heart attack, a stroke, stent thrombosis, or dying from an event related to the heart or blood vessels.
To answer this question, the researchers checked the participants’ heart and blood vessel health at different times throughout the trial. The researchers then recorded the number of participants who experienced:
- a heart attack
- a stroke
- stent thrombosis
- death caused by an event related to the heart or blood vessels
Overall, the researchers found that the percentage of participants who experienced these events was:
- 6.8% of the participants who took 10 mg of BAY 2433334. This was 27 out of 397 participants.
- 6.0% of the participants who took 20 mg of BAY 2433334. This was 24 out of 401 participants.
- 5.5% of the participants who took 50 mg of BAY 2433334. This was 22 out of 402 participants.
- 5.5% of the participants who took the placebo. This was 22 out of 401 participants.The difference between BAY 2433334 and the placebo was too small for the researchers to know if BAY 2433334 helped to reduce the number of participants who experienced another heart attack, a stroke, stent thrombosis, or dying from an event related to the heart of blood vessels compared to the placebo. The difference could have been due to chance.
Did a similar number of participants who took BAY 2433334 need medical care for bleeding compared to those who took the placebo?
Yes. Overall, the researchers found that a similar number of participants who took BAY 2433334 needed medical care for bleeding compared to the participants who took the placebo.
To answer this question, the researchers kept track of internal and external bleeding that participants had while taking the trial treatments. Researchers were specifically interested in knowing when participants had certain types of bleedings. These were bleedings that:
- caused death
- happened near important body parts or organs
- led to a high amount of blood loss
- needed medical helpThere were 8 participants who left this trial before taking any trial treatments. So, the results for the question below only include 1,593 participants.
Overall, the researchers found that the percentage of participants who experienced these types of bleeding was:
- 7.6% of the participants who took 10 mg of BAY 2433334. This was 30 out of 395 participants.
- 8.1% of the participants who took 20 mg of BAY 2433334. This was 32 out of 397 participants.
- 10.5% of the participants who took 50 mg of BAY 2433334. This was 42 out of 402 participants.
- 9.0% of the participants who took the placebo. This was 36 out of 399 participants.The researchers concluded that the number of participants who needed medical care for bleeding was similar between the participants who took BAY 2433334 and the participants who took the placebo.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0170
Date of REC Opinion
30 Jul 2020
REC opinion
Favourable Opinion