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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007536-25 | EudraCT Number | EudraCT |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran 110 mg | Experimental | experimental drug therapy in this indication |
|
| Dabigatran 150 mg | Experimental | experimental drug therapy in this indication |
|
| Unfractionated Heparin | Active Comparator | standard therapy in this indication as comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran 110 mg | Drug | comparison of different dabigatran dosages with unfractionated heparin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | Investigator reported outcome | From 22 to 165 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | Investigator reported outcome | From 22 to 165 minutes |
| Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.73.31004 Boehringer Ingelheim Investigational Site | Alkmaar | Netherlands | ||||
| 1160.73.31003 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23182947 | Derived | Vranckx P, Verheugt FW, de Maat MP, Ulmans VA, Regar E, Smits P, ten Berg JM, Lindeboom W, Jones RL, Friedman J, Reilly P, Leebeek FW. A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients. EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran 110mg Bis in Die (BID) | |
| FG001 | Dabigatran 150mg Bis in Die (BID) | |
| FG002 | Heparin | Unfractionated heparin administered during intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran 110mg Bis in Die (BID) | |
| BG001 | Dabigatran 150mg Bis in Die (BID) | |
| BG002 | Heparin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis | Investigator reported outcome | Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention | Posted | Number | Percentage of participants | From 22 to 165 minutes |
|
First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran 110mg Bis in Die (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
Although a total of 50 patients are included in the FAS, 4 of these patients did not have data for the primary endpoint and are therefore not included in the odd ratio calculation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| dabigatran 150 mg | Drug | comparison of different dabigatran dosages with unfractionated heparin |
|
| unfractionated heparin | Drug | comparison of different dosages dabigatran with unfractionated heparin |
|
Investigator reported outcome |
| From 22 to 165 minutes |
| Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | Investigator reported outcome | From 22 to 165 minutes |
| 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). | First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) |
| Nieuwegein |
| Netherlands |
| 1160.73.1 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands |
| 1160.73.31002 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands |
| Randomised and not treated |
|
Unfractionated heparin administered during intervention
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All participants were white | Number | participants |
|
| Creatinine clearance | Baseline creatinine clearance was not available for 3 patients in the Dabigatran 110mg treatment group. | Mean | Standard Deviation | mL/min |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy | Investigator reported outcome | Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention | Posted | Number | Percentage of participants | From 22 to 165 minutes |
|
|
|
| Secondary | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow | Investigator reported outcome | Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention | Posted | Number | Percentage of participants | From 22 to 165 minutes |
|
|
|
| Secondary | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis | Investigator reported outcome | Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention | Posted | Number | Percentage of participants | From 22 to 165 minutes |
|
|
|
| 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). | Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug. | Posted | Number | participants | First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) |
|
|
|
| 1 |
| 20 |
| 4 |
| 20 |
| EG001 | Dabigatran 150mg Bis in Die (BID) | 0 | 21 | 3 | 21 |
| EG002 | Heparin | Unfractionated heparin administered during intervention | 0 | 10 | 3 | 10 |
| Feeling cold | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Coronary artery occulsion | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Postinfaction angina | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Puncture site haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |