Trial results of Pradaxa® vs ASA in ESUS published in NEJM

  • First Phase III randomised clinical trial to compare dabigatran
    etexilate and acetylsalicylic acid (ASA)
  • No significant difference in recurrent stroke prevention after ESUS
  • Dabigatran showed no significant difference in major bleeding

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim today announced full results from the RE-SPECT ESUS®
trial, a Phase III randomised, double-blind study investigating the
efficacy and safety of Pradaxa® (dabigatran etexilate) versus
acetylsalicylic acid (ASA) in preventing recurrent stroke in patients
with embolic stroke of undetermined source (ESUS). The results were
published in the New England Journal of Medicine (NEJM).1

The trial did not meet its primary endpoint, which was to show a
clinically significant difference between dabigatran etexilate and ASA
on reducing the risk of a recurrent stroke among post-stroke patients
with ESUS. However, a post-hoc analysis showed a treatment effect
emerged in favour of dabigatran after one year.1 The safety
results from the trial demonstrated that the risk of major bleeding was
not significantly different between dabigatran etexilate and ASA.1 A
comparable low risk for the most serious bleeding outcomes, such as
intracranial haemorrhage, was shown.1

As the first ever comparative trial to investigate dabigatran etexilate
versus ASA, the results add to the wealth of evidence supporting the
established safety profile of dabigatran etexilate, which has already
been demonstrated in its approved indications in the extensive
RE-VOLUTION® clinical trial and registry programme.2-24

“The results from RE-SPECT ESUS provide highly interesting information,
showing that dabigatran had a similar low risk of major bleeding
compared to ASA in this high-risk population of post-stroke patients.
This clearly reaffirms the positive risk-benefit profile of dabigatran,”
said Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic
Medicine, Boehringer Ingelheim.

ESUS is a type of cryptogenic stroke, which is when an ischaemic stroke
has an unknown cause.25 A stroke is classified as an ESUS
when other potential diagnoses have been ruled out.25,26
Overall, one in six ischaemic strokes are classified as ESUS.25 Following
an ESUS, most patients are treated with anti-platelet therapy, such as
ASA27;however, one in three go on to have a
recurrent stroke within five years.28

Pradaxa is not approved in any country for patients with ESUS.

Randomised, double-blind, evaluation in secondary stroke prevention
comparing the efficacy and safety of the oral thrombin inhibitor
dabigatran etexilate vs. acetylsalicylic acid (ASA) in patients with
embolic stroke of undetermined source (RE-SPECT ESUS

RE-SPECT ESUS® was a Phase III, double-blind trial of
dabigatran vs ASA for secondary stroke prevention in patients with ESUS
and involved 5,390 patients from more than 40 countries. Patients were
randomised to receive dabigatran etexilate 150 mg BID, adjusted to 110mg
BID for patients above 75 years or with impaired renal function, and a
placebo matching ASA 100 mg or ASA 100 mg and a placebo matching
dabigatran etexilate. The primary endpoint of the trial was to show a
clinically significant difference between dabigatran etexilate and ASA
on the risk of a recurrent stroke among post-stroke patients with ESUS.1

Please click on the following link for ‘Notes to Editors’ and

Intended audiences:

This press release is issued from our Corporate Headquarters in
Ingelheim, Germany and is intended to provide information about our
global business. It is directed to the international audience outside
Germany. Please be aware that information relating to the approval
status and labels of approved products may vary from country to country,
and a country-specific press release on this topic may have been issued
in the countries where we do business.


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