Trial Outcomes & Findings for Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT) (NCT NCT02348723)
NCT ID: NCT02348723
Last Updated: 2018-01-29
Results Overview
Major bleeds were defined according to the ISTH definition of a major bleed, 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 associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or * Fatal bleed These are based on adjudicated data (blinded evaluation) Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
678 participants
Primary outcome timeframe
during and up to 2 months post-ablation
Results posted on
2018-01-29
Participant Flow
Patients were randomly assigned to dabigatran etexilate 150 mg twice daily or warfarin in a 1:1 ratio and remained on this treatment for the duration of the trial. 678 subjects were randomised and 676 were treated.
Participant milestones
| Measure |
Dabigatran Etexilate 150 mg
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Overall Study
STARTED
|
338
|
338
|
|
Overall Study
COMPLETED
|
310
|
312
|
|
Overall Study
NOT COMPLETED
|
28
|
26
|
Reasons for withdrawal
| Measure |
Dabigatran Etexilate 150 mg
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Overall Study
No ablation
|
21
|
20
|
|
Overall Study
Non-compliant with Protocol
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Consent withdrawn
|
1
|
3
|
|
Overall Study
Reason other than specified
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
Baseline Characteristics
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate 150 mg
n=338 Participants
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=338 Participants
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.29 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during and up to 2 months post-ablationPopulation: The ablation set (AS) was the primary analysis set and included all patients in the treated set (TS) who started the ablation procedure
Major bleeds were defined according to the ISTH definition of a major bleed, 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 associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or * Fatal bleed These are based on adjudicated data (blinded evaluation) Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented.
Outcome measures
| Measure |
Dabigatran Etexilate 150 mg
n=317 Participants
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=318 Participants
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)
|
1.6 percentage of participants
Interval 0.2 to 2.9
|
6.9 percentage of participants
Interval 4.1 to 9.7
|
SECONDARY outcome
Timeframe: during and up to 2 months post-ablationPopulation: AS
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. These are based on adjudicated data (blinded evaluation). Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented
Outcome measures
| Measure |
Dabigatran Etexilate 150 mg
n=317 Participants
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=318 Participants
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)
|
0.0 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: during and up to 2 months post-ablationPopulation: AS
Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented. These are based on adjudicated data (blinded evaluation)
Outcome measures
| Measure |
Dabigatran Etexilate 150 mg
n=317 Participants
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=318 Participants
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Incidence of Minor Bleeding Events
|
18.6 percentage of participants
|
17.0 percentage of participants
|
SECONDARY outcome
Timeframe: during and up to 2 months post-ablationPopulation: AS
Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented. These are based on adjudicated data (blinded evaluation)
Outcome measures
| Measure |
Dabigatran Etexilate 150 mg
n=317 Participants
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=318 Participants
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy
|
1.6 percentage of participants
|
7.2 percentage of participants
|
Adverse Events
Dabigatran Etexilate 150 mg
Serious events: 63 serious events
Other events: 68 other events
Deaths: 0 deaths
Warfarin
Serious events: 75 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate 150 mg
n=338 participants at risk
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=338 participants at risk
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
1.2%
4/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Facial paralysis
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
General disorders
Chest pain
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.89%
3/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
General disorders
Malaise
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
General disorders
Polyp
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
General disorders
Pyrexia
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Anal abscess
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Bacteraemia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Groin abscess
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Infections and infestations
Lung infection
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
6/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
3.8%
13/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Atrial flutter
|
5.9%
20/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
5.6%
19/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Atrial tachycardia
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Atrial thrombosis
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Bradycardia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Cardiac failure
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.89%
3/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Cardiac tamponade
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
1.2%
4/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Palpitations
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Pericardial effusion
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Pericarditis
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Right ventricular failure
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Sinus arrest
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Sinus node dysfunction
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Tachycardia
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Eye disorders
Conjunctival haemorrhage
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Renal and urinary disorders
Urinary retention
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.59%
2/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.89%
3/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
1.8%
6/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
0.30%
1/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
Other adverse events
| Measure |
Dabigatran Etexilate 150 mg
n=338 participants at risk
Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID);
1 capsule 150 mg twice daily (total daily dose 300 mg)
|
Warfarin
n=338 participants at risk
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
11.8%
40/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
11.2%
38/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Cardiac disorders
Palpitations
|
4.7%
16/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
5.6%
19/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
18/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
4.1%
14/338 • All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER