Trial Outcomes & Findings for Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery (NCT NCT00847301)
NCT ID: NCT00847301
Last Updated: 2015-09-25
Results Overview
Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Recruitment status
COMPLETED
Target enrollment
472 participants
Primary outcome timeframe
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Results posted on
2015-09-25
Participant Flow
There were 472 patients entered into the study, 428 were treated with moderate renal impairment. Treated patients with moderate renal impairment are presented.
Participant milestones
| Measure |
Overall Study Design
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
|
|---|---|
|
Overall Study
STARTED
|
428
|
|
Overall Study
COMPLETED
|
374
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Overall Study Design
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
|
|---|---|
|
Overall Study
Adverse Event
|
35
|
|
Overall Study
Switch to other anticoagulants
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
No prescription after hospital discharge
|
1
|
|
Overall Study
Other reason not defined above
|
1
|
Baseline Characteristics
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
Baseline characteristics by cohort
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Age, Continuous
|
78.6 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
324 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected; clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
Outcome measures
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Percentage of Patients With Major Bleeding Events (MBE)
|
2.10 percentage of participants
Interval 0.97 to 3.95
|
PRIMARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.
Outcome measures
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
|
0.70 percentage of Participants
Interval 0.14 to 2.03
|
SECONDARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
Outcome measures
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
symptomatic distal DVT
|
0.23 percentage of participants
Interval 0.01 to 1.29
|
|
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
symptomatic proximal DVT
|
0.0 percentage of participants
Interval 0.0 to 0.86
|
|
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
symptomatic non-fatal PE
|
0.23 percentage of participants
Interval 0.01 to 1.29
|
|
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
All-cause mortality
|
0.23 percentage of participants
Interval 0.01 to 1.29
|
SECONDARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
Percentage of Patients With Major Extra-surgical Site Bleedings
Outcome measures
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Percentage of Patients With Major Extra-surgical Site Bleedings
|
1.87 percentage of Participants
Interval 0.81 to 3.65
|
SECONDARY outcome
Timeframe: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of PradaxaPopulation: Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
Volume of Wound Drainage after surgery
Outcome measures
| Measure |
All Patients
n=428 Participants
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Volume of Wound Drainage (Post-operative)
|
685.2 ml
Standard Deviation 404.1
|
Adverse Events
All Patients
Serious events: 34 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=468 participants at risk
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
5/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.64%
3/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
General disorders
Catheter site haemorrhage
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
General disorders
Inflammation
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
General disorders
Oedema peripheral
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Infections and infestations
Arthritis infective
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Infections and infestations
Pneumonia
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Infections and infestations
Postoperative wound infection
|
0.43%
2/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Infections and infestations
Sepsis
|
0.43%
2/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Investigations
Hepatic enzyme increased
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Nervous system disorders
Dizziness
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Nervous system disorders
Petit mal epilepsy
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Nervous system disorders
Syncope
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Psychiatric disorders
Confusional state
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Renal and urinary disorders
Renal failure
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.43%
2/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Renal and urinary disorders
Renal impairment
|
0.43%
2/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Vascular disorders
Circulatory collapse
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Vascular disorders
Haematoma
|
0.64%
3/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
2/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Scar
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.21%
1/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
|
Other adverse events
| Measure |
All Patients
n=468 participants at risk
All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.1%
24/468 • From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 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 Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER