Heart Catheterization
Conditions
Brief summary
To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).
Interventions
DRUGdabigatran 110 mg
comparison of different dabigatran dosages with unfractionated heparin
comparison of different dabigatran dosages with unfractionated heparin
DRUGunfractionated heparin
comparison of different dosages dabigatran with unfractionated heparin
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients between 18 and 85 years * due to undergo elective PCI * informed consent obtained
Exclusion criteria
* PCI lesion specific conditions * class III or IV congestive heart failure * severe hypertension * increased bleeding risk * thrombolytic therapy within 24 hours preceding randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | From 22 to 165 minutes | Investigator reported outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | From 22 to 165 minutes | Investigator reported outcome |
| Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | From 22 to 165 minutes | Investigator reported outcome |
| Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | From 22 to 165 minutes | Investigator reported outcome |
| Number of Participants With Bleeding Events | First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) | 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). |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran 110mg Bis in Die (BID) | 22 |
| Dabigatran 150mg Bis in Die (BID) | 21 |
| Heparin Unfractionated heparin administered during intervention | 10 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other reason (not specified) | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Randomised and not treated | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Dabigatran 110mg Bis in Die (BID) | Dabigatran 150mg Bis in Die (BID) | Heparin | Total |
|---|---|---|---|---|
| Age, Continuous | 65.5 Years STANDARD_DEVIATION 8.7 | 63.0 Years STANDARD_DEVIATION 8.5 | 67.0 Years STANDARD_DEVIATION 8.3 | 64.8 Years STANDARD_DEVIATION 8.5 |
| Creatinine clearance | 98.5 mL/min STANDARD_DEVIATION 38.2 | 96.3 mL/min STANDARD_DEVIATION 19.3 | 95.7 mL/min STANDARD_DEVIATION 26.5 | 97.0 mL/min STANDARD_DEVIATION 28.6 |
| Race/Ethnicity, Customized | 22 participants | 21 participants | 10 participants | 53 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 7 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 20 | 3 / 21 | 3 / 10 |
| serious Total, serious adverse events | 1 / 20 | 0 / 21 | 0 / 10 |
Outcome results
Primary
Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
Investigator reported outcome
Time frame: From 22 to 165 minutes
Population: Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Dabigatran 110mg Bis in Die (BID) | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | 10.5 Percentage of participants | 10.5 |
| Dabigatran 150mg Bis in Die (BID) | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | 14.3 Percentage of participants | 14.3 |
| Heparin | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | 10.0 Percentage of participants | 10 |
Comparison: Dabigatran 110mg BID vs Heparin95% CI: [0.08, 12.76]Cochran-Mantel-Haenszel
Comparison: Dabigatran 150mg BID vs Heparin95% CI: [0.13, 16.82]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Bleeding Events
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran 110mg Bis in Die (BID) | Number of Participants With Bleeding Events | 0 participants |
| Dabigatran 150mg Bis in Die (BID) | Number of Participants With Bleeding Events | 0 participants |
| Heparin | Number of Participants With Bleeding Events | 1 participants |
Secondary
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
Investigator reported outcome
Time frame: From 22 to 165 minutes
Population: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Dabigatran 110mg Bis in Die (BID) | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | 10.5 Percentage of participants | 2 |
| Dabigatran 150mg Bis in Die (BID) | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | 4.8 Percentage of participants | 1 |
| Heparin | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | 0 Percentage of participants | 0 |
Secondary
Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis
Investigator reported outcome
Time frame: From 22 to 165 minutes
Population: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Dabigatran 110mg Bis in Die (BID) | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | 0 Percentage of participants | 0 |
| Dabigatran 150mg Bis in Die (BID) | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | 0 Percentage of participants | 0 |
| Heparin | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | 0 Percentage of participants | 0 |
Secondary
Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
Investigator reported outcome
Time frame: From 22 to 165 minutes
Population: Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Dabigatran 110mg Bis in Die (BID) | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | 0 Percentage of participants | 0 |
| Dabigatran 150mg Bis in Die (BID) | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | 0 Percentage of participants | 0 |
| Heparin | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | 0 Percentage of participants | 0 |