Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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).

Official Title
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The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization

Conditions
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Heart Catheterization

Intervention / Treatment
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* Drug: dabigatran 110 mg
* Drug: dabigatran 150 mg
* Drug: unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dabigatran 110 mg<br>experimental drug therapy in this indication | Drug: dabigatran 110 mg<br>* comparison of different dabigatran dosages with unfractionated heparin<br>|
| Experimental: Dabigatran 150 mg<br>experimental drug therapy in this indication | Drug: dabigatran 150 mg<br>* comparison of different dabigatran dosages with unfractionated heparin<br>|
| Active Comparator: Unfractionated Heparin<br>standard therapy in this indication as comparator | Drug: unfractionated heparin<br>* comparison of different dosages dabigatran with unfractionated heparin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |