Trial Outcomes & Findings for Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention (NCT NCT00818753)
NCT ID: NCT00818753
Last Updated: 2014-06-09
Results Overview
Investigator reported outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
From 22 to 165 minutes
Results posted on
2014-06-09
Participant Flow
Participant milestones
| Measure |
Dabigatran 110mg Bis in Die (BID)
|
Dabigatran 150mg Bis in Die (BID)
|
Heparin
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
10
|
|
Overall Study
COMPLETED
|
19
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dabigatran 110mg Bis in Die (BID)
|
Dabigatran 150mg Bis in Die (BID)
|
Heparin
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Other reason (not specified)
|
0
|
0
|
1
|
|
Overall Study
Randomised and not treated
|
2
|
0
|
0
|
Baseline Characteristics
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=22 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
67.0 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
64.8 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
10 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Creatinine clearance
|
98.5 mL/min
STANDARD_DEVIATION 38.2 • n=5 Participants
|
96.3 mL/min
STANDARD_DEVIATION 19.3 • n=7 Participants
|
95.7 mL/min
STANDARD_DEVIATION 26.5 • n=5 Participants
|
97.0 mL/min
STANDARD_DEVIATION 28.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: From 22 to 165 minutesPopulation: Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention
Investigator reported outcome
Outcome measures
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=19 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
|
10.5 Percentage of participants
10.5
|
14.3 Percentage of participants
14.3
|
10.0 Percentage of participants
10
|
SECONDARY outcome
Timeframe: From 22 to 165 minutesPopulation: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
Investigator reported outcome
Outcome measures
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=19 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
|
0 Percentage of participants
0
|
0 Percentage of participants
0
|
0 Percentage of participants
0
|
SECONDARY outcome
Timeframe: From 22 to 165 minutesPopulation: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
Investigator reported outcome
Outcome measures
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=19 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
|
10.5 Percentage of participants
2
|
4.8 Percentage of participants
1
|
0 Percentage of participants
0
|
SECONDARY outcome
Timeframe: From 22 to 165 minutesPopulation: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
Investigator reported outcome
Outcome measures
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=19 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis
|
0 Percentage of participants
0
|
0 Percentage of participants
0
|
0 Percentage of participants
0
|
SECONDARY outcome
Timeframe: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)Population: Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug.
Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).
Outcome measures
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=20 Participants
|
Dabigatran 150mg Bis in Die (BID)
n=21 Participants
|
Heparin
n=10 Participants
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Number of Participants With Bleeding Events
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Dabigatran 110mg Bis in Die (BID)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dabigatran 150mg Bis in Die (BID)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Heparin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=20 participants at risk
|
Dabigatran 150mg Bis in Die (BID)
n=21 participants at risk
|
Heparin
n=10 participants at risk
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
Other adverse events
| Measure |
Dabigatran 110mg Bis in Die (BID)
n=20 participants at risk
|
Dabigatran 150mg Bis in Die (BID)
n=21 participants at risk
|
Heparin
n=10 participants at risk
Unfractionated heparin administered during intervention
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
9.5%
2/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
General disorders
Feeling cold
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
4.8%
1/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Cardiac disorders
Coronary artery occulsion
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Vascular disorders
Ischaemia
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
10.0%
1/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Cardiac disorders
Postinfaction angina
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Vascular disorders
Thrombosis
|
5.0%
1/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
10.0%
1/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
10.0%
1/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
|
Gastrointestinal disorders
Puncture site haemorrhage
|
0.00%
0/20 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
0.00%
0/21 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
10.0%
1/10 • First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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