Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00818753
First received: January 7, 2009
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Catheterization |
Drug: dabigatran 110 mg Drug: dabigatran 150 mg Drug: unfractionated heparin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization |
Resource links provided by NLM:
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Heparin
Dabigatran
Dabigatran etexilate
Dabigatran etexilate mesylate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]Investigator reported outcome
Secondary Outcome Measures:
- Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]Investigator reported outcome
- Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]Investigator reported outcome
- Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis [ Time Frame: From 22 to 165 minutes ] [ Designated as safety issue: No ]Investigator reported outcome
| Enrollment: | 53 |
| Study Start Date: | January 2009 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dabigatran 110 mg
experimental drug therapy in this indication
|
Drug: dabigatran 110 mg
comparison of different dabigatran dosages with unfractionated heparin
|
|
Experimental: Dabigatran 150 mg
experimental drug therapy in this indication
|
Drug: dabigatran 150 mg
comparison of different dabigatran dosages with unfractionated heparin
|
|
Active Comparator: Unfractionated Heparin
standard therapy in this indication as comparator
|
Drug: unfractionated heparin
comparison of different dosages dabigatran with unfractionated heparin
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818753
Locations
| Netherlands | |
| 1160.73.31004 Boehringer Ingelheim Investigational Site | |
| Alkmaar, Netherlands | |
| 1160.73.31003 Boehringer Ingelheim Investigational Site | |
| Nieuwegein, Netherlands | |
| 1160.73.31002 Boehringer Ingelheim Investigational Site | |
| Rotterdam, Netherlands | |
| 1160.73.1 Boehringer Ingelheim Investigational Site | |
| Rotterdam, Netherlands | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00818753 History of Changes |
| Other Study ID Numbers: | 1160.73, 2007-007536-25 |
| Study First Received: | January 7, 2009 |
| Results First Received: | August 5, 2011 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Netherlands: Central Committee Research Involving Human Subjects |
Additional relevant MeSH terms:
|
Calcium heparin Heparin Anticoagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013