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Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Phase 3 trial testing optional ASA as comedication in Stroke in 5,390 participants. Completed in 14 August 2018.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 5,390 |
| Start date | 27 November 2014 |
| Primary completion | 14 August 2018 |
| Estimated completion | 14 August 2018 |
| Sites | 569 locations across Hong Kong, Colombia, Italy, Japan, Malaysia, Taiwan, Poland, South Korea |
Boehringer Ingelheim — full company profile →
Adults 18 to 150, any sex, with Stroke or Secondary Prevention. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 4.09 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 4.80 |
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
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 1.84 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 1.33 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 3.97 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 4.71 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 4.80 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 5.40 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 0.55 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0.93 |
All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 1.24 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 1.28 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 0.67 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0.63 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 0.00 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0.05 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 0.76 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 0.91 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dabigatran Etexilate 110 or 150 Milligram (mg) | 15.21 | |
| Acetylsalicylic Acid, Aspirin (ASA) 100 mg | 11.64 |
Time frame: Adverse Events (AE) and serious AE starting between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. All-cause mortality reported from randomisation until full follow up period, approximately 43 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dabigatran Etexilate 110 o… | Acetylsalicylic Acid, Aspi… |
|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | — | — |
| Ischaemic stroke | Nervous system disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Cerebral infarction | Nervous system disorders | — | — |
| Atrial fibrillation or atrial flutter | Cardiac disorders | — | — |
| Epilepsy | Nervous system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Seizure | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Hypertensive crisis | Vascular disorders | — | — |
| Atrial flutter | Cardiac disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Reaction | System | Dabigatran Etexilate 110 o… | Acetylsalicylic Acid, Aspi… |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
Most-reported serious reactions: Cerebrovascular accident, Ischaemic stroke, Transient ischaemic attack, Cerebral infarction, Atrial fibrillation or atrial flutter, Epilepsy, Atrial fibrillation, Fall.
Data from ClinicalTrials.gov NCT02239120 adverse events section.
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).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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