Neoplasms

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Nervous System Diseases

Heart and Blood Diseases

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Stroke

Embolic Stroke

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Ischemia

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Platelet Aggregation Inhibitors

All Drugs and Chemicals

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Aspirin

Dabigatran

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Serine

Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)

All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d

optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

optional ASA as comedication

placebo to ASA

placebo to optional ASA as comedication

placebo to dabigatran etexilate

ASA 100 mg

dabigatran etexilate

Boehringer Ingelheim

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.

First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:

* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,
* Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,
* Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.

Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.

Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.

Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.

All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.

Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.

The annualised event rate represents the average number of events per patient during a 1-year period.

Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.

Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.

The annualised event rate represents the average number of events per patient during a 1-year period.

This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.

The annualised event rate represents the average number of events per patient during a 1-year period.

All-cause mortality numbers are based on randomized set whereas Serious Adverse Events (SAE) and non-SAE are based on treated set.

Participants were orally administered one 110 mg (for participants aged ≥75 years or with a creatinine clearance (CrCl) of 30 to \<50 millilitre/ minute (mL/min)) or one 150 mg (for participants aged \<75 years and with a CrCl of ≥50 mL/minute) Dabigatran etexilate (DE) capsule twice daily.

Dabigatran Etexilate 110 or 150 Milligram (mg)

Participants were orally administered one 100 mg Aspirin non-enteric coated tablet once daily.

Acetylsalicylic Acid, Aspirin (ASA) 100 mg

Total

Age, Continuous

Sex: Female, Male

Information on race and ethnicity was not collected for all patients in France.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Randomised set (RS): The RS consisted of all patients who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.

Boehringer Ingelheim, Call Centre

Randomised set (RS): RS consisted of all participants who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.

Adjudicated Recurrent Stroke

Treated set (TS): TS consisted of all patients who were treated with at least 1 dose of trial medication. The start date of the observation period for this population was the date of first intake of trial medication.

Spots Global Cancer Trial Database for placebo to dabigatran etexilate