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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE (RE-SONATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558259
First received: November 13, 2007
Last updated: June 17, 2014
Last verified: February 2014
Results First Received: January 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID)
Drug: matching placebo twice daily (BID)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 3 patients randomised to placebo who received Dabigatran only. For all analyses of efficacy, these patients are analysed as randomised. For all analyses of safety, these patients are analysed as treated.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid (twice daily)
Placebo Matching placebo

Participant Flow:   Overall Study
    Dabigatran   Placebo
STARTED   681 [1]   662 [2] 
COMPLETED   610 [3]   563 [3] 
NOT COMPLETED   71   99 
Adverse Event                50                81 
Protocol Violation                9                5 
Withdrawal by Subject                12                13 
[1] Number who started treatment. There were 4 patients randomised to Dabigatran and not treated.
[2] Number who started treatment. There were 6 patients randomised to placebo and not treated.
[3] Completed treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
   Dabigatran   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 681   662   1343 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.1  (15.5)   55.5  (15.1)   55.8  (15.3) 
Gender 
[Units: Participants]
     
Female   300   298   598 
Male   381   364   745 
Body mass index (BMI) continuous 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.45  (5.44)   28.41  (5.56)   28.43  (5.50) 


  Outcome Measures
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1.  Primary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]

2.  Secondary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]

3.  Secondary:   Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period   [ Time Frame: 6 months ]

4.  Secondary:   Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period   [ Time Frame: 6 months ]

5.  Secondary:   Centrally Confirmed Unexplained Deaths During the Intended Treatment Period   [ Time Frame: 6 months ]

6.  Secondary:   Centrally Confirmed Bleeding Event During the Treatment Period   [ Time Frame: 6 months ]

7.  Secondary:   Centrally Confirmed Cardiovascular Events During the Treatment Period   [ Time Frame: 6 months ]

8.  Secondary:   Laboratory Measures, Especially Liver Function Tests (LFTs)   [ Time Frame: 6 months ]


  Serious Adverse Events
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Time Frame 6 months
Additional Description There were 3 patients who were randomised to placebo but who were treated with dabigatran only.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid
Placebo Matching placebo

Serious Adverse Events
    Dabigatran   Placebo
Total, serious adverse events     
# participants affected / at risk   47/684 (6.87%)   60/659 (9.10%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Splenomegaly † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   1/684 (0.15%)   1/659 (0.15%) 
Angina pectoris † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Atrial fibrillation † 1     
# participants affected / at risk   0/684 (0.00%)   2/659 (0.30%) 
Cardiac failure † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Hypertensive heart disease † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Ear and labyrinth disorders     
Vertigo † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Eye disorders     
Amaurosis fugax † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Optic ischaemic neuropathy † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Abdominal pain upper † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Colitis † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Colonic polyp † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Enteritis † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Gastric ulcer † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Gastric ulcer haemorrhage † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Gastritis † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Haematemesis † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Inguinal hernia † 1     
# participants affected / at risk   0/684 (0.00%)   2/659 (0.30%) 
Nausea † 1     
# participants affected / at risk   1/684 (0.15%)   1/659 (0.15%) 
Rectal haemorrhage † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Vomiting † 1     
# participants affected / at risk   1/684 (0.15%)   1/659 (0.15%) 
General disorders     
Chest pain † 1     
# participants affected / at risk   2/684 (0.29%)   1/659 (0.15%) 
Oedema † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Pain † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Polyp † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   0/684 (0.00%)   2/659 (0.30%) 
Unevaluable event † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Hepatobiliary disorders     
Cholestasis † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Infections and infestations     
Abscess limb † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Anal abscess † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Arthritis infective † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Lobar pneumonia † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Pneumonia † 1     
# participants affected / at risk   2/684 (0.29%)   2/659 (0.30%) 
Salmonella bacteraemia † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Salmonellosis † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Urinary tract infection † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   1/684 (0.15%)   2/659 (0.30%) 
Femur fracture † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Head injury † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Joint injury † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Post procedural haemorrhage † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Radius fracture † 1     
# participants affected / at risk   2/684 (0.29%)   0/659 (0.00%) 
Rib fracture † 1     
# participants affected / at risk   0/684 (0.00%)   3/659 (0.46%) 
Scapula fracture † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Skin laceration † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Thermal burn † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Arthrofibrosis † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Back pain † 1     
# participants affected / at risk   2/684 (0.29%)   0/659 (0.00%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Musculoskeletal pain † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Osteoarthritis † 1     
# participants affected / at risk   2/684 (0.29%)   0/659 (0.00%) 
Rheumatoid arthritis † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma pancreas † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Breast neoplasm † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Chronic lymphocytic leukaemia † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Colon cancer † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Gastric cancer † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Lung adenocarcinoma † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Lung neoplasm † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Metastases to bladder † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Ovarian neoplasm † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Prostate cancer † 1     
# participants affected / at risk   1/684 (0.15%)   1/659 (0.15%) 
Rectal cancer stage I † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Squamous cell carcinoma † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Nervous system disorders     
Chronic inflammatory demyelinating polyradiculoneuropathy † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Diabetic hyperglycaemic coma † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Hydrocephalus † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Ischaemic stroke † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Nerve compression † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Psychiatric disorders     
Personality disorder † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   2/684 (0.29%)   4/659 (0.61%) 
Dyspnoea † 1     
# participants affected / at risk   1/684 (0.15%)   2/659 (0.30%) 
Lung disorder † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Pleural effusion † 1     
# participants affected / at risk   2/684 (0.29%)   0/659 (0.00%) 
Pneumothorax † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Pulmonary artery thrombosis † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Pulmonary embolism † 1     
# participants affected / at risk   1/684 (0.15%)   16/659 (2.43%) 
Pulmonary hypertension † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Pulmonary infarction † 1     
# participants affected / at risk   0/684 (0.00%)   2/659 (0.30%) 
Surgical and medical procedures     
Abdominal wall operation † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   2/684 (0.29%)   15/659 (2.28%) 
Embolism venous † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Essential hypertension † 1     
# participants affected / at risk   1/684 (0.15%)   0/659 (0.00%) 
Haematoma † 1     
# participants affected / at risk   0/684 (0.00%)   1/659 (0.15%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.1




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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